FDA 510(k) clearance · back to tracker
Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
Biomet Orthopedics, Inc. cleared K253515 on 2026-08-24, decision: substantially equivalent
K-number
K253515
Sponsor
Biomet Orthopedics, Inc.
Device
Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-08-24
Product code
JDI
Advisory committee
Orthopedic
Medical specialty
Orthopedic
Regulation number
888.3350
Official FDA record
Open K253515on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.