Centinel Spine, LLC
West Chester, PA, US
CENTINEL SPINE, LLC appears in FDA device records in West Chester, PA. FDA records list 14 510(k) clearances between and , 53 PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Centinel Spine, LLC between 2010 and 2025. The busiest year on record is 2014, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 3 |
| 2018 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250554 | prodisc® L Instruments | QLQ | Substantially Equivalent | |
| K242869 | prodisc® L Instruments | QLQ | Substantially Equivalent | |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | QLQ | Substantially Equivalent | |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | MAX | Substantially Equivalent | |
| K152211 | PCT System | NKG | Substantially Equivalent | |
| K150053 | STALIF C; STALIF C-Ti | OVE | Substantially Equivalent | |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | OVD | Substantially Equivalent | |
| K141942 | MIDLINE II TI | OVD | Substantially Equivalent | |
| K142079 | STALIF CTI, STALIF C | OVE | Substantially Equivalent | |
| K133200 | STALIF C(R) | OVE | Substantially Equivalent | |
| K133286 | MIDLINE (TM) | OVD | Substantially Equivalent | |
| K130461 | STALIF X | OVD | Substantially Equivalent | |
| K120819 | STALIF C | OVE | Substantially Equivalent | |
| K101301 | STALIF MIDLINE | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007494564 | 3007494564 | CENTINEL SPINE, LLC | 900 Airport Rd Ste 3B, West Chester, PA 19380 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- QLQManual Instruments Designed For Use With Total Disc Replacement Devices
- LXHOrthopedic Manual Surgical Instrument
- NKGPosterior Cervical Screw System
- MJOProsthesis, Intervertebral Disc
- HTRRasp
- HTXRongeur
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2051-2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. 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. | Class II | Open, Classified | |
| Z-2050-2026 | 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. | Class II | Open, Classified | |
| Z-1426-2026 | 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. | Class II | Open, Classified | |
| Z-3213-2024 | prodisc C SK, Total cervical disc replacement, 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. | Class II | Open, Classified | |
| Z-3212-2024 | 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. | Class II | Open, Classified | |
| Z-1406-2021 | 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 disease (SCDD), Part number: 09.820.055S | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain