M6-C Artificial Cervical Disc
FDA premarket approval P170036/S013 · decided 2023-06-14
Approval details
- PMA number
- P170036
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- M6-C Artificial Cervical Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Spinal Kinetics, LLC
- Date received
- 2023-06-02
- Decision date
- 2023-06-14
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Addition of a packaging seal test unit identical to the existing unit in operation (BT lntegra Pack Tester).
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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 |