510(k) clearance
Integrity Retractable Implant Inserter (6000127)
- 510(k) number
- K261869
- Applicant
- Anika Therapeutics, Inc.
- Decision date
- Sep 17, 2026
- Date received
- Jun 4, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MBI
- Device type
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Beford, MA, US