prodisc L Total Disc Replacement
FDA premarket approval P050010/S021 · decided 2020-05-08
Approval details
- PMA number
- P050010
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- prodisc L Total Disc Replacement
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2019-07-30
- Decision date
- 2020-05-08
- Days to decision
- 283 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- Approval for additional cleaning, passivation and thermal rinse steps, and the following four (4) manufacturing sites, at the following addresses, and for the following purposes:Centinel Spine (Manufacturer)900 Airport Road Suite 3BWest Chester, PA 19380Hammill Medical (Contract Manufacturer)360 Tomahawk DriveMaumee, OH 43537Fruh Verpackungstechnik AG (Contract Manufacturer)Allmendstrasse 47Fehraltoff Switzerland 8320Synergy Health Daniken AG (Contract Sterilizer)Hogenweidstrasse 6Daniken Soloth
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| prodisc® L Instruments (K242869) | Centinel Spine, LLC | 2024-12-17 |
| prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) | Centinel Spine, LLC | 2022-08-19 |