ACTIVL ARTIFICIAL DISC
FDA premarket approval P120024/S003 · decided 2015-12-17
Approval details
- PMA number
- P120024
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ACTIVL ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2015-11-18
- Decision date
- 2015-12-17
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGES TO THE REPORTING TIMELINE AND ACTIVL® SURGEON SURVEY.
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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 |