Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE— 510(k) K121277

Name: FDA 510(k) clearance K121277
Creator: U.S. Food and Drug Administration
Published: 2012-11-07

Substantially Equivalent

Z-Medical GmbH & Co. KG

FDA 510(k) clearance K121277 for Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE, Substantially Equivalent on 2012-11-07. Applicant: Z-Medical GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Z-Medical GmbH & Co. KG
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2012-04-27
Decision date: 2012-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, Baden-Wuerttemberg, DE

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.