TGM Biolox delta Ceramic Heads— 510(k) K150576

Substantially Equivalent

Tgm Medical, Inc.

FDA 510(k) clearance K150576 for TGM Biolox delta Ceramic Heads, Substantially Equivalent on 2015-09-09. Applicant: Tgm Medical, Inc..

Clearance details

Applicant: Tgm Medical, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2015-03-06
Decision date: 2015-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.