K250844
- 510(k) number
- K250844
- Device name
- PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop
- Applicant
- Science & Bio Materials (S.B.M.) Sas FR
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-06-02
- Date received
- 2025-03-20
- 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: K250844.pdf
Official FDA record: K250844
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.