Integrity Retractable Implant Inserter (6000127)— 510(k) K261869
Substantially EquivalentAnika Therapeutics, Inc.
FDA 510(k) clearance K261869 for Integrity Retractable Implant Inserter (6000127), Substantially Equivalent on 2026-09-17. Applicant: Anika Therapeutics, Inc.. Device class: 2.
Summary
Integrity Retractable Implant Inserter (6000127) is from Anika Therapeutics, Inc., filed under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). The record gives the catalog number and no other detail.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
The record lists Anika's location as Beford, Massachusetts. The decision came 105 calendar days after FDA received it (June 4 to September 17, 2026).
Clearance details
- Applicant
- Anika Therapeutics, Inc.
- Product code
- Product code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beford, MA, US
Recent devices under product code MBI
view allMore clearances from Anika Therapeutics, Inc.
view allAdverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.