Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw— 510(k) K170571

Name: FDA 510(k) clearance K170571
Creator: U.S. Food and Drug Administration
Published: 2017-06-20

Substantially Equivalent

Tyber Medical, LLC

FDA 510(k) clearance K170571 for Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw, Substantially Equivalent on 2017-06-20. Applicant: Tyber Medical, LLC. Device class: 2.

Clearance details

Applicant: Tyber Medical, LLC
Product code: Product code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2017-02-27
Decision date: 2017-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.