Company · US
Centinel Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (1 in 12 months)
6recalls (3 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | 6 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| NKG | Posterior Cervical Screw System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2026 | K263159 | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments Centinel Spine, LLC | QLQ |
| Apr 25, 2025 | K250554 | prodisc® L Instruments Centinel Spine, LLC | QLQ |
| Dec 17, 2024 | K242869 | prodisc® L Instruments Centinel Spine, LLC | QLQ |
| Aug 19, 2022 | K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments Centinel Spine, LLC | QLQ |
| May 8, 2018 | 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 Centinel Spine, Inc. | MAX |
| Dec 1, 2015 | K152211 | PCT System Centinel Spine, Inc. | NKG |
| Jun 24, 2015 | K150053 | STALIF C; STALIF C-Ti Centinel Spine, Inc. | OVE |
| Jun 8, 2015 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti Centinel Spine, Inc. | OVD |
| Nov 7, 2014 | K141942 | MIDLINE II TI Centinel Spine, Inc. | OVD |
| Oct 24, 2014 | K142079 | STALIF CTI, STALIF C Centinel Spine, Inc. | OVE |
| May 8, 2014 | K133200 | STALIF C(R) Centinel Spine, Inc. | OVE |
| Jan 9, 2014 | K133286 | MIDLINE (TM) Centinel Spine, Inc. | OVD |
| Aug 28, 2013 | K130461 | STALIF X Centinel Spine, Inc. | OVD |
| Aug 31, 2012 | K120819 | STALIF C Centinel Spine, Inc. | OVE |
| Sep 24, 2010 | K101301 | STALIF MIDLINE Centinel Spine | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Centinel Spine, Inc. Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6.
Total cervical disc replacement. Open, Classified |
MJO | None listed |
| May 1, 2026 | Centinel Spine, Inc. Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5
Total cervical disc replacement. Open, Classified |
MJO | None listed |
| Feb 17, 2026 | Centinel Spine, Inc. Brand Name: Prodisc
Product Name: Prodisc C SK
Model/Catalog Number: PDSL6
Software Version: N/A
Product Description: Total cervical disc replacement
Component: No Open, Classified |
MJO | None listed |
| Sep 24, 2024 | Centinel Spine, Inc. prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 Open, Classified |
MJO | None listed |
| Sep 24, 2024 | Centinel Spine, Inc. prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5 Open, Classified |
MJO | None listed |
| Mar 5, 2021 | Centinel Spine, Inc. 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 symptom Terminated |
MJO | None listed |