M6-C Artificial Cervical Disc
FDA premarket approval P170036 · decided 2019-02-06
Approval details
- PMA number
- P170036
- Trade name
- M6-C Artificial Cervical Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Spinal Kinetics, LLC
- Date received
- 2017-10-31
- Decision date
- 2019-02-06
- Days to decision
- 463 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Approval for the M6-C Artificial Cervical Disc. The M6-C Artificial Cervical Disc is indicated for reconstruction of the disc following single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 to C7. Degenerative cervical radiculopathy is defined as arm pain and/or a neurological deficit (numbness, weakness, deep tendon reflexes changes) with or without neck pain due to disc herniation
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| M6-C Artificial Cervical Disc Instruments AS (K220861) | Spinal Kinetics, LLC | 2022-06-02 |