Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Centinel Spine with 15 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Oct 7, 2026: prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 7, 2026 | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo InstrumentsK263159 · QLQ | 510(k) clearances |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.Class II · 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 | Device recalls |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.Class II · 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 | Device recalls |
| Dec 31, 2025 | Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disClass II · Products were mislabeled as the 6mm product but included the 5 mm product. | Device recalls |
| Apr 25, 2025 | prodisc® L InstrumentsK250554 · QLQ | 510(k) clearances |
| Dec 17, 2024 | prodisc® L InstrumentsK242869 · QLQ | 510(k) clearances |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5Class II · During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considere | Device recalls |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5Class II · During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considere | Device recalls |
| Aug 19, 2022 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsK221848 · QLQ | 510(k) clearances |
| Mar 5, 2021 | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-Class II · Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior pl | Device recalls |
| May 8, 2018 | 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 FLXK173347 · MAX | 510(k) clearances |
| Dec 1, 2015 | PCT SystemK152211 · NKG | 510(k) clearances |
| Jun 24, 2015 | STALIF C; STALIF C-TiK150053 · OVE | 510(k) clearances |
| Jun 8, 2015 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiK150643 · OVD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
