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Depuy Spine, Inc.

Last updated September 17, 2026

What Depuy Spine, Inc. makes

Depuy Spine, Inc. manufactures reusable instrument trays for surgical procedures, spinal implant trial devices, and polymeric spinal interbody fusion cages. Their portfolio includes non-bioabsorbable spinal bone screws, internal spinal fixation systems with rods and connectors, and endoscopic light source units. Orthopaedic inorganic implant inserters/extractors are also part of their offerings.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. Depuy Spine, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Depuy Spine, Inc. manufacture?

Depuy Spine, Inc. specializes in spinal and orthopaedic devices, including reusable surgical instrument trays, spinal implant trial tools, and polymeric spinal interbody fusion cages. Their portfolio also covers non-bioabsorbable spinal bone screws, internal spinal fixation systems (comprising rods and connectors), endoscopic light source units, and reusable orthopaedic implant inserters/extractors. These devices are designed for spinal stabilization, fusion, and surgical assistance.

Where is Depuy Spine, Inc. based?

Depuy Spine, Inc. is headquartered in the United States. The company’s location is relevant for regulatory inquiries, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).

Which regulatory registries list Depuy Spine, Inc.’s devices?

Depuy Spine, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and clinical purposes.

How are Depuy Spine, Inc.’s devices classified by the FDA?

Depuy Spine, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional regulations due to moderate risk. The classification depends on factors like intended use, potential harm, and procedural complexity, as outlined in FDA guidelines.

What is the significance of Depuy Spine, Inc.’s device classifications?

The FDA’s classification system determines the regulatory pathway for each device. Class I devices typically require basic compliance with general controls, such as proper labeling and manufacturing practices. Class II devices, however, may need pre-market notifications (510(k)) or other submissions to demonstrate safety and effectiveness, as they involve higher risks or novel technologies. This classification ensures appropriate oversight based on the device’s purpose and potential impact on patient safety.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 325 Paramount Drive, RAYNHAM, MA, 02767
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1526439
DUNS Number: —

Catalogue (4164)

Page 6 of 84

Device	Model / Reference	Registries	Class	Status
Isola	205054	FDA UDI	Class I	Active
Timx	202586	FDA UDI	Class I	Unknown
Bengal	277303014	FDA UDI	Class I	Unknown
Monarch	277493850	FDA UDI	Class I	Unknown
Viper	286705010	FDA UDI	Class I	Active
Expedium	186242530	FDA UDI	Class II	Unknown
Expedium	186254360	FDA UDI	Class II	Unknown
Uniplate	189722040	FDA UDI	Class II	Active
Alif	273506290	FDA UDI	Class I	Active
Summit	274679014	FDA UDI	Class I	Unknown
Devex	286402000	FDA UDI	Class I	Active
Expedium	186102565	FDA UDI	Class II	Active
Isola	5003115	FDA UDI	Class II	Unknown
Isola	50001025	FDA UDI	Class II	Unknown
Isola	50103245	FDA UDI	Class II	Unknown
Ocelot	273420008	FDA UDI	Class I	Active
Cougar	287101050	FDA UDI	Class I	Active
Cougar	273215216	FDA UDI	Class I	Active
Plif	273127003	FDA UDI	Class I	Unknown
Eagle Swift	286570600	FDA UDI	Class I	Unknown
Moss	175574000	FDA UDI	Class II	Active
Expedium	286280300	FDA UDI	Class I	Active
Bengal	177306160	FDA UDI	Class II	Active
Expedium	186242535	FDA UDI	Class II	Unknown
Kaneda Sr	52012850	FDA UDI	Class II	Unknown
Mountaineer	288390810	FDA UDI	Class I	Unknown
Keystone	282104016	FDA UDI	Class I	Active
Expedium	186252380	FDA UDI	Class II	Unknown
Expedium	186122530	FDA UDI	Class II	Active
Aegis	187160026	FDA UDI	Class II	Active
Skyline	286850100	FDA UDI	Class I	Active
Isola	500085107	FDA UDI	Class II	Unknown
Monarch	177037745	FDA UDI	Class II	Unknown
Healos	276160010	FDA UDI	Class II	Unknown
Keystone	282105100	FDA UDI	Class I	Active
Isola	500062	FDA UDI	Class II	Unknown
Cougar	287101051	FDA UDI	Class I	Active
Isola	500038	FDA UDI	Class II	Unknown
Isola	500077207	FDA UDI	Class II	Unknown
Concorde	287900112	FDA UDI	Class I	Active
Moss	275015110	FDA UDI	Class I	Unknown
Expedium	279763920	FDA UDI	Class I	Unknown
Expedium	186202565	FDA UDI	Class II	Unknown
Monarch	277050100	FDA UDI	Class I	Active
Bengal	273330041	FDA UDI	Class I	Active
Slim-Loc	279620012	FDA UDI	Class I	Unknown
Isola	2230525	FDA UDI	Class II	Unknown
Isola	500037	FDA UDI	Class II	Unknown
Bengal	177306162	FDA UDI	Class II	Active
Monarch	177008580	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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FDA Recalls (57)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Depuy Spine, Inc. has 57 recall records initiated between October 10, 2006, and May 20, 2022, with statuses recorded as open, classified, or terminated. The reasons cited include mechanical failures such as jamming in cement mixers, premature wear in torque wrenches, and potential breakage of drivers. Labeling discrepancies, incorrect component inclusion, and sterility compromises due to package integrity issues were also noted. Additional concerns involved misalignment of devices, incorrect etching on screw caddies, and potential disassociation of polyaxial screws under specific conditions.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 20, 2022	Z-1324-2022	—	open, classified	Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
May 20, 2022	Z-1323-2022	—	open, classified	Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
Apr 8, 2019	Z-1225-2019	—	terminated	A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Apr 8, 2019	Z-1226-2019	—	terminated	A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Dec 15, 2017	Z-1300-2018	—	terminated	Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
Oct 12, 2016	Z-0627-2017	—	terminated	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Oct 12, 2016	Z-0628-2017	—	terminated	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Oct 12, 2016	Z-0629-2017	—	terminated	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Oct 12, 2016	Z-0624-2017	—	terminated	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Oct 12, 2016	Z-0626-2017	—	terminated	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Oct 12, 2016	Z-0625-2017	—	terminated	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Oct 12, 2016	Z-0630-2017	—	terminated	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Nov 20, 2015	Z-0454-2016	—	terminated	Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
Apr 21, 2015	Z-1674-2015	—	terminated	Device does not mate as intended.
Jul 31, 2013	Z-0096-2014	—	terminated	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Jul 31, 2013	Z-0095-2014	—	terminated	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Jul 31, 2013	Z-0093-2014	—	terminated	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Jul 31, 2013	Z-0097-2014	—	terminated	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Jul 31, 2013	Z-0094-2014	—	terminated	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Apr 17, 2013	Z-2132-2013	—	terminated	During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Apr 17, 2013	Z-2134-2013	—	terminated	During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Apr 17, 2013	Z-2133-2013	—	terminated	During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Jan 15, 2013	Z-0963-2013	—	terminated	Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Jan 15, 2013	Z-0961-2013	—	terminated	Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Jan 15, 2013	Z-0960-2013	—	terminated	Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Jan 15, 2013	Z-0962-2013	—	terminated	Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Nov 7, 2012	Z-0708-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Nov 7, 2012	Z-0707-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Nov 7, 2012	Z-0706-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Nov 7, 2012	Z-0705-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Nov 7, 2012	Z-0710-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Nov 7, 2012	Z-0713-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Nov 7, 2012	Z-0709-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Nov 7, 2012	Z-0711-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Nov 7, 2012	Z-0712-2013	—	terminated	Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Jul 24, 2012	Z-0685-2013	—	terminated	A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.
Mar 22, 2011	Z-2102-2011	—	terminated	Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
Mar 22, 2011	Z-2103-2011	—	terminated	Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
Oct 2, 2010	Z-0818-2011	—	terminated	The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy
Oct 2, 2010	Z-0819-2011	—	terminated	The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy
Oct 2, 2010	Z-0817-2011	—	terminated	The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy
Feb 11, 2009	Z-1670-2009	—	terminated	Tip of Driver may break during use
Oct 10, 2006	Z-0134-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0136-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0143-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0130-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0138-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0140-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0135-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0133-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0131-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0132-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0141-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0142-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0144-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0139-2007	—	terminated	Sterility of device is compromised due to loss of package integrity
Oct 10, 2006	Z-0137-2007	—	terminated	Sterility of device is compromised due to loss of package integrity