M6-C Artificial Cervical Disc
FDA premarket approval P170036/S008 · decided 2021-08-06
Approval details
- PMA number
- P170036
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- M6-C Artificial Cervical Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Spinal Kinetics, LLC
- Date received
- 2020-12-22
- Decision date
- 2021-08-06
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Approval for Infinity Labs SD located at 1836 Stone Avenue, San Jose, California, 95125, for ethylene oxide sterilization of the M6-C Artificial Cervical Disc system.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| M6-C Artificial Cervical Disc Instruments AS (K220861) | Spinal Kinetics, LLC | 2022-06-02 |