Chrysalis Intelligence · Sponsors · Centinel Spine, LLC

Centinel Spine, LLC

West Chester, PA, US · 3 510(k) clearances · 20 PMAs · 6 recalls

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Total clearances
3
2022-08-19 → 2025-04-25
Last 12 months
0
Product codes
1
Most recent
2025-04-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices Class II Orthopedic 3 2025-04-25
Class III

PMA approvals (20)

Total PMA records
20
Originals + supplements
Distinct product codes
1
First decision
2020-04-10
Most recent
2026-09-09
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-09 P070001-S031 prodisc® C Nova Normal 180 Day Track MJO Prosthesis, Intervertebral Disc Unknown
2026-01-15 P070001-S030 prodisc® C 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2025-10-10 P070001-S025 prodisc C SK and prodisc C Vivo Panel Track MJO Prosthesis, Intervertebral Disc Unknown
2025-09-02 P050010-S027 PRODISC L Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
2025-07-30 P070001-S029 prodisc® C 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2025-07-30 P050010-S028 prodisc L 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2025-06-04 P070001-S028 prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
2025-06-04 P050010-S025 PRODISC -L TOTAL DISC REPLACEMENT DEVICE Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
2025-01-17 P050010-S026 prodisc® L 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2024-08-07 P070001-S027 prodisc C 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2024-03-01 P070001-S026 prodisc - C and prodisc - C Nova (Indicated for Single Level Use) Special (Immediate Track) MJO Prosthesis, Intervertebral Disc Unknown
2023-11-08 P070001-S024 prodisc® C Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
2023-11-08 P050010-S024 prodisc® L Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
2022-07-07 P070001-S019 prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo Normal 180 Day Track MJO Prosthesis, Intervertebral Disc Unknown
2021-10-28 P070001-S021 prodisc® C 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2021-03-15 P050010-S023 prodisc L 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2021-02-23 P070001-S020 prodisc C 30-Day Notice MJO Prosthesis, Intervertebral Disc Unknown
2020-05-08 P070001-S018 prodisc C Total Disc Replacement Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
2020-05-08 P050010-S021 prodisc L Total Disc Replacement Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
2020-04-10 P050010-S020 prodisc L Total Disc Replacement Panel Track MJO Prosthesis, Intervertebral Disc Unknown
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
5
Most recent
2026-03-20
DateSeverityStatusRecall # ProductCodeReason
2026-03-20 Class II Ongoing 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 la…
2026-03-20 Class II Ongoing 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 la…
2025-12-31 Class II Ongoing Z-1426-2026 Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description… — Products were mislabeled as the 6mm product but included the 5 mm product.
2024-07-18 Class II Ongoing 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 hav…
2024-07-18 Class II Ongoing 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 hav…
2021-03-05 Class II Terminated Z-1406-2021 Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction … — 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 Sur…
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-04-25 K250554 prodisc® L Instruments QLQ Class II Orthopedic
2024-12-17 K242869 prodisc® L Instruments QLQ Class II Orthopedic
2022-08-19 K221848 prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments QLQ Class II Orthopedic
Data source: openFDA · Generated 2026-09-23 11:01 · Last ingest 2026-09-23T15:00:49.349277 · Pipeline: Chrysalis Intelligence