Tecomet Global Unite Short Stem Instrumentation— 510(k) K211553

Substantially Equivalent

Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.

FDA 510(k) clearance K211553 for Tecomet Global Unite Short Stem Instrumentation, Substantially Equivalent on 2021-08-04. Applicant: Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc..

Clearance details

Applicant: Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2021-05-19
Decision date: 2021-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.