ACTIVL ARTIFICIAL DISC
FDA premarket approval P120024/S002 · decided 2015-11-04
Approval details
- PMA number
- P120024
- Supplement
- S002
- Supplement type
- Real-Time Process
- 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
- 2015-08-07
- Decision date
- 2015-11-04
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL FOR CHANGES TO THE ACTIVL® ARTIFICIAL DISC LABELING THAT PROPOSED CHANGES TO THE INSTRUCTIONS FOR USE, SURGICAL TECHNIQUE, PATIENT BROCHURE, AND PACKAGE LABEL TO REFLECT THE MR TESTING THAT WAS CONDUCTED.
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| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
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