K231968
- 510(k) number
- K231968
- Device name
- Tactoset® Injectable Bone Substitute
- Applicant
- Anika Therapeutics, Inc. MA · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2023-12-20
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231968.pdf
Official FDA record: K231968
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.