K253515
- 510(k) number
- K253515
- Device name
- Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
- Applicant
- Biomet Orthopedics, Inc. IN · US
- Product code
- JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Ce
- Decision date
- 2026-08-24
- Date received
- 2025-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253515.pdf
Official FDA record: K253515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.