ACTIVL ARTIFICIAL DISC
FDA premarket approval P120024/S004 · decided 2017-06-20
Approval details
- PMA number
- P120024
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACTIVL ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2016-12-23
- Decision date
- 2017-06-20
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Approval for labeling changes to the surgical technique and for the addition of the Class III activL® Slim Trial Instruments and the activL® Artificial Disc Ancillary Trialing & Confirmation instrument tray to the system
Class III intelligence, same tools
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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 |