activeL Artificial Disc
FDA premarket approval P120024/S008 · decided 2019-05-13
Approval details
- PMA number
- P120024
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- activeL Artificial Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2019-03-29
- Decision date
- 2019-05-13
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Approval for MR Conditional labeling for the activeL keel endplates.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
| Virage® OCT Spinal Fixation System (K250332) | Highridge Medical, LLC | 2025-04-04 |