Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007494564

FEI Number

3007494564

Entity Name

CENTINEL SPINE, LLC

City/State/Country

West Chester, PA, US

Establishment Address

900 Airport Rd Ste 3B, West Chester, PA 19380, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Centinel Spine, LLC (Owner Number: 10026981)

Owner / Operator Contact Address

900 Airport Rd, Suite 3B, West Chester, PA 19380, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prodisc C Prodisc L Stalif C Rongeur Stalif Lumbar Rasp, Various sizes Stalif C Tapered Rasp, Various sizes Stalif Midline Lumbar Stem Rasp, Various sizes STALIF C Flexible Awl Guide, Various Sizes STALIF Midline Flexible Awl Guide, Various Sizes STALIF TT Flexible Awl Guide, Various sizes Prodisc L Total Disc Replacement Manual Instruments STALIF C trial sizers - Various sizes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2018-09-26
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2018-06-13
HTX	Rongeur	Orthopedic	Class 1	888.4540	2008-12-12
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2012-12-11
HWJ	Awl	Orthopedic	Class 1	888.4540	2008-12-12
QLQ	Manual Instruments Designed For Use With Total Disc Replacement Devices	Orthopedic	Class 2	888.4515	2025-01-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-09-10

Official Correspondent

Jessica Staub

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Centinel Spine, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3009973336	Engineered Medical Systems, LLC	Bartlett, TN, US
1530390	HAMMILL MFG. CO.	MAUMEE, OH, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3012447612	Highridge Medical, LLC	Westminster, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007494564. Last updated year: 2026. Please use registration number 3007494564 when referencing this establishment in official correspondence.