TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM— 510(k) K101206

Name: FDA 510(k) clearance K101206
Creator: U.S. Food and Drug Administration
Published: 2010-07-23

Substantially Equivalent

Alexandria Research Technologies, LLC

FDA 510(k) clearance K101206 for TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM, Substantially Equivalent on 2010-07-23. Applicant: Alexandria Research Technologies, LLC. Device class: 2.

Clearance details

Applicant: Alexandria Research Technologies, LLC
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 2010-04-30
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.