TiTHON Staple with OsseoTi Technology— 510(k) K151615

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K151615 for TiTHON Staple with OsseoTi Technology, Substantially Equivalent on 2015-10-02. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2015-06-15
Decision date: 2015-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.