Comprehensive Nano Stemless Shoulder— 510(k) K182516

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K182516 for Comprehensive Nano Stemless Shoulder, Substantially Equivalent on 2019-04-22. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code PKC
Advisory panel: Orthopedic
Date received: 2018-09-13
Decision date: 2019-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.