K251961
- 510(k) number
- K251961
- Device name
- SDS Growing Rod
- Applicant
- BAAT Medical Products B.V. NL
- Product code
- PGM — Growing Rod System
- Decision date
- 2026-01-15
- Date received
- 2025-06-26
- 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: K251961.pdf
Official FDA record: K251961
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.