K252664
- 510(k) number
- K252664
- Device name
- GMReis Suture Anchors
- Applicant
- GM Dos Reis Industria e Comercio Ltda. BR
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-11-04
- Date received
- 2025-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252664.pdf
Official FDA record: K252664
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.