510(k) clearance
Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments
- 510(k) number
- K253515
- Applicant
- Biomet Orthopedics, Inc.
- Decision date
- Aug 24, 2026
- Date received
- Nov 7, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JDI
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II
- Regulation
- 21 CFR 888.3350
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Warsaw, IN, US