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Centinel Spine, LLC

United States·US-MF-000013245

Last updated September 17, 2026

What Centinel Spine, LLC makes

Centinel Spine, LLC manufactures spinal fixation and replacement devices, including non-sterile bone-screw internal fixation systems for spinal stabilization, sterile and metal-polymer composite spinal fusion cages for interbody fusion, and modular cervical and lumbar total intervertebral disc prostheses for joint replacement.

The company’s products are classified as Class II and Class III devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer 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 Centinel Spine, LLC manufacture?

Centinel Spine, LLC specializes in spinal devices, including non-sterile bone-screw internal fixation systems for stabilizing the spine, sterile and metal-polymer composite spinal fusion cages for promoting bone growth between vertebrae, and modular cervical and lumbar total intervertebral disc prostheses designed to replace damaged spinal discs. These products address spinal stabilization, fusion, and joint replacement needs.

Where is Centinel Spine, LLC based?

The company is headquartered in the United States. This location aligns with regulatory frameworks governing medical device manufacturing and distribution in North America.

Which regulatory registries list Centinel Spine, LLC’s devices?

Centinel Spine’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify product details and compliance.

How are Centinel Spine, LLC’s devices classified under FDA regulations?

The company’s devices fall into two FDA classification categories: Class II and Class III. Class II devices generally pose moderate risk and require special controls beyond general controls, while Class III devices are higher risk and require pre-market approval due to insufficient data to ensure safety and effectiveness through other means.

What distinguishes Centinel Spine’s spinal fusion cages from other fixation systems?

Centinel Spine offers both sterile polymeric spinal fusion cages and metal-polymer composite cages, which combine materials to enhance structural support and bone integration. These are designed for interbody fusion, where cages are placed between vertebrae to promote healing, while their non-sterile bone-screw systems focus on direct spinal stabilization without fusion goals. The modular disc prostheses further extend functionality for joint replacement.

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

Information

Country: United States
Address: Suite 3B, 900 Airport Road, PA, United States
Website: www.centinelspine.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 0049 7333 925 99 80
PRRC Contact: Hoda El Outmani
EUDAMED SRN: US-MF-000013245
FDA FEI Number: 3007494564
DUNS Number: —

Catalogue (993)

Page 19 of 20

Device	Model / Reference	Registries	Class	Status
prodisc® L Instruments	K242869	FDA 510(k)	Class II	Active
Stalif X	K130461	FDA 510(k)	Class II	Active
Stalif Cti, Stalif C	K142079	FDA 510(k)	Class II	Active
GuidingArm f/PE-Inlay le	PDL652	EUDAMED	Class I	Active
Spreader 9mm Height	03.809.875	EUDAMED	Class I	Active
INSERTER TIPS XL/XLD 7mm	03.820.142	EUDAMED	Class I	Active
Chisel 12mm	SFW868R	EUDAMED	Class I	Active
Osteotome w/15	PDL632	EUDAMED	Class I	Active
Chisel - 6mm	03.820.286	EUDAMED	Class I	Active
Strut Straight - 10mm/6°/190mm	SFW541	EUDAMED	Class I	Active
Lever	SFW582R	EUDAMED	Class I	Active
Remover Clamp - M/Md	03.670.400	EUDAMED	Class I	Active
Handle For Strut	SFW520	EUDAMED	Class I	Active
GuidingBlock siz L H12	PDL610	EUDAMED	Class I	Active
INSERTER TIPS M/MD 7mm	03.820.132	EUDAMED	Class I	Active
Driver, Self-Retaining	03.820.101	EUDAMED	Class I	Active
Distractor 10mm	SFW874R	EUDAMED	Class I	Active
Retainer Screw 4.5mm X 19mm	03.820.109	EUDAMED	Class I	Active
Strut Straight - 12mm/6°/150mm	SFW522	EUDAMED	Class I	Active
Spacer Clamp, Xl/Xld - 5mm	03.670.325	EUDAMED	Class I	Active
Spacer Clamp, Xl/Xld - 6mm	03.670.326	EUDAMED	Class I	Active
GuidingBlock siz M H14	PDL606	EUDAMED	Class I	Active
Bone Elevator	SFW580R	EUDAMED	Class I	Active
Osteotome slotted w/18	PDL630	EUDAMED	Class I	Active
Spacer Clamp, M/Md - 6mm	03.670.306	EUDAMED	Class I	Active
Trial Holder Handle	03.820.204	EUDAMED	Class I	Active
Implant Holder, Xl/Xld	03.670.203	EUDAMED	Class I	Active
Strut 11° f/10 Rev	PDL660	EUDAMED	Class I	Active
Trial Holder Shaft - 7mm	03.820.281	EUDAMED	Class I	Active
Spreader 11mm Height	03.809.876	EUDAMED	Class I	Active
INSERTER TIPS M/MD 6mm	03.820.131	EUDAMED	Class I	Active
GuidingBlock siz L H14	PDL612	EUDAMED	Class I	Active
Chisel - 5mm	03.820.285	EUDAMED	Class I	Active
Strut Straight - 10mm/6°/170mm	SFW531	EUDAMED	Class I	Active
Retainer Screw 3.5mm X 16mm	03.820.104	EUDAMED	Class I	Active
Spacer Clamp, L/Ld - 6mm	03.670.316	EUDAMED	Class I	Active
Handle for Positioner	03.670.205	EUDAMED	Class I	Active
Retainer Screw 4.5mm X 13mm	03.820.106	EUDAMED	Class I	Active
Remover Clamp - Xl/Xld	03.670.420	EUDAMED	Class I	Active
GuidingBlock siz M H10	PDL602	EUDAMED	Class I	Active
INSERTER TIPS XL/XLD 5mm	03.820.140	EUDAMED	Class I	Active
Slide Hammer For Cervical Spine	03.820.282	EUDAMED	Class I	Active
Stop For Implant Holder	03.670.212	EUDAMED	Class I	Active
INSERTER TIPS L/LD 7mm	03.820.135	EUDAMED	Class I	Active
Slotted Mallet	03.820.113	EUDAMED	Class I	Active
Retainer Screw 4.5mm X 17mm	03.820.108	EUDAMED	Class I	Active
Distractor 12mm	SFW875R	EUDAMED	Class I	Active
Spreader 13mm Height	03.809.877	EUDAMED	Class I	Active
Vertebral Body Spreader- Angled	SFW650R OR SFW550R	EUDAMED	Class I	Active
Awl 12mm	03.820.100	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

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

Centinel Spine, LLC has six FDA recall records initiated between March 5, 2021, and March 20, 2026. The records include open, classified, and terminated statuses, with reasons involving product labeling errors—such as incorrect size labeling for the Prodisc C implants—and manufacturing issues, including missing markings on surgical components and potential foreign contamination in device inlays.

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
Mar 20, 2026	Z-2051-2026	—	open, classified	Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Mar 20, 2026	Z-2050-2026	—	open, classified	Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Dec 31, 2025	Z-1426-2026	—	open, classified	Products were mislabeled as the 6mm product but included the 5 mm product.
Jul 18, 2024	Z-3212-2024	—	open, classified	During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Jul 18, 2024	Z-3213-2024	—	open, classified	During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Mar 5, 2021	Z-1406-2021	—	terminated	Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.