Data / Medical devices / United States / Centinel Spine, LLC

Centinel Spine, LLC: FDA-registered device maker in West Chester, PA, United States, 4 510(k) clearances and 2 PMA approvals

Name: Centinel Spine, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Centinel Spine, LLC is registered with the FDA (registration 3007494564) in West Chester, PA, United States. It lists 9 device types. The FDA files 4 510(k) clearances and 2 PMA approvals under its listings, the newest dated October 7, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007494564
Address: 900 Airport Rd Ste 3B, West Chester, PA, United States, 19380
Owner or operator: Centinel Spine, LLC (10026981)
Roles: Complaint file establishment, Specification developer
First device listed: September 10, 2008
Registered through: 2027
Brand names listed: Prodisc C, Prodisc C Nova, Prodisc C Removal Instruments, Prodisc C SK, Prodisc C Vivo, Prodisc L, Prodisc L Total Disc Replacement Manual Instruments, STALIF C Flexible Awl Guide, Various Sizes and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Specification developer	accessdata.fda.gov
Bit, Surgical	GFG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Manual Instruments Designed For Use With Total Disc Replacement Devices	QLQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Intervertebral Disc	MJO	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Rasp	HTR	1	Specification developer	accessdata.fda.gov
Rongeur	HTX	1	Specification developer	accessdata.fda.gov
Tray, Surgical	LRP	1	Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 7, 2026	K263159	prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments	QLQ	Substantially Equivalent	Centinel Spine, LLC	accessdata.fda.gov
April 25, 2025	K250554	prodisc® L Instruments	QLQ	Substantially Equivalent	Centinel Spine, LLC	accessdata.fda.gov
December 17, 2024	K242869	prodisc® L Instruments	QLQ	Substantially Equivalent	Centinel Spine, LLC	accessdata.fda.gov
August 19, 2022	K221848	prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments	QLQ	Substantially Equivalent	Centinel Spine, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 17, 2007	P070001	PRODISC TM-C TOTAL DISC REPLACEMENT	MJO	27	September 9, 2026	accessdata.fda.gov
August 14, 2006	P050010	PRODISC -L TOTAL DISC REPLACEMENT DEVICE	MJO	25	September 2, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 20, 2026	98721	Class II	Ongoing	Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.	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.	accessdata.fda.gov
December 31, 2025	98282	Class II	Ongoing	Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No	Products were mislabeled as the 6mm product but included the 5 mm product.	accessdata.fda.gov
July 18, 2024	95164	Class II	Ongoing	prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5	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.	accessdata.fda.gov
March 5, 2021	87530	Class II	Terminated	Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc d	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	accessdata.fda.gov

Compare with other makers

Updated October 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.