Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDepuy Spine, Inc.
US
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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1526439
- DUNS Number
- —
Catalogue (4164)
Page 84 of 84| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Expedium Mis Spine System | K041801 | FDA 510(k) | Class II | Active |
| Merlin Spine System | K033901 | FDA 510(k) | Class II | Active |
| Pipeline Ii Access System | K062814 | FDA 510(k) | Class II | Active |
| Expedium Spine System | K063741 | FDA 510(k) | Class II | Active |
| Healos Fx Bone Graft Substitute And Graft Mixing And Delivery System | K062495 | FDA 510(k) | Class II | Active |
| Expedium Spine System | K070387 | FDA 510(k) | Class II | Active |
| Modification To Expedium Spine System | K090799 | FDA 510(k) | Class II | Active |
| Modification To: Viper Spine System | K071860 | FDA 510(k) | Class II | Active |
| Uniplate Anterior Cervical Plate System | K082273 | FDA 510(k) | Class II | Active |
| Expedium Spine System | K090230 | FDA 510(k) | Class II | Active |
| Modification To: Expedium Spine System | K092626 | FDA 510(k) | Class II | Active |
| Veper System, Expedium System | K103133 | FDA 510(k) | Class II | Active |
| Lumbar I/F Cage With Vsp Spine System | P960025 | FDA PMA | Class III | Active |
| Charite Artificial Disc | P040006 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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 |