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

Name: FDA 510(k) clearance K211553
Creator: U.S. Food and Drug Administration
Published: 2021-08-04

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.. Device class: 2.

Clearance details

Applicant: Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
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 ↗

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K253992 — Veritas Reverse Total Shoulder System2026-05-07

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.