ACTIVL ARTIFICIAL DISC
FDA premarket approval P120024 · decided 2015-06-11
Approval details
- PMA number
- P120024
- Trade name
- ACTIVL ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2012-12-18
- Decision date
- 2015-06-11
- Days to decision
- 905 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL FOR THE ACTIVL® ARTIFICIAL DISC. THIS DEVICE IS INDICATED FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL (L4-L5 OR L5-S1) FOLLOWING SINGLE-LEVEL DISCECTOMY IN SKELETALLY MATURE PATIENTS WITH SYMPTOMATIC DEGENERATIVE DISC DISEASE (DDD) WITH NO MORE THAN GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, PHYSICAL EXAMINATION, AND RADIOGRAPHIC STUDIES. THE ACTIVL® ARTIFICIAL DISC IS IMPLANTED USIN
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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 |