Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length— 510(k) K213580

Substantially Equivalent

Total Joint Othopedics, Inc.

FDA 510(k) clearance K213580 for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length, Substantially Equivalent on 2021-12-03. Applicant: Total Joint Othopedics, Inc..

Clearance details

Applicant: Total Joint Othopedics, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2021-11-10
Decision date: 2021-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, 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.