Barricaid® Annular Closure Device
FDA premarket approval P160050/S011 · decided 2025-12-18
Approval details
- PMA number
- P160050
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Barricaid® Annular Closure Device
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2025-11-18
- Decision date
- 2025-12-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- approval for manufacturing process changes to the delivery instrument of the Barricaid Annular Closure Device
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.