Barricaid® Annular Closure Device
FDA premarket approval P160050/S010 · decided 2025-10-09
Approval details
- PMA number
- P160050
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Barricaid® Annular Closure Device
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2025-02-03
- Decision date
- 2025-10-09
- Days to decision
- 248 days
- Decision code
- APPR
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- approval for a new 6mm baseplate sized implant.
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