Anika Therapeutics, Inc.
FDA Regulatory Profile
Anika Therapeutics, Inc. appears in FDA public data with 1 recall, 11 510(k) clearances, 13 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2423-2018, Class II) was initiated on May 10, 2018. Its most recent 510(k) clearance was granted on September 17, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 11
- Inspections
- 13
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2423-2018 | Class II | Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi- | May 10, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261869 | Integrity Retractable Implant Inserter (6000127) | September 17, 2026 |
| K261311 | HYALOMATRIX | September 2, 2026 |
| K250997 | Integrity Implant | June 17, 2025 |
| K231968 | Tactoset® Injectable Bone Substitute | December 20, 2023 |
| K223538 | Integrity Implant | August 17, 2023 |
| K223860 | Integrity Bone Staple Fixation System | May 22, 2023 |
| K222487 | Anika Tissue Tack Fixation System | May 8, 2023 |
| K223915 | Tactoset | March 29, 2023 |
| K212083 | Tactoset Injectable Bone Substitute | August 31, 2021 |
| K190956 | SCS 17-01 | January 30, 2020 |
| K173008 | SCS 17-01 | December 26, 2017 |