KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN— 510(k) K961522

Substantially Equivalent

Synvasive Technology, Inc.

FDA 510(k) clearance K961522 for KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN, Substantially Equivalent on 1996-09-23. Applicant: Synvasive Technology, Inc..

Clearance details

Applicant: Synvasive Technology, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1996-04-22
Decision date: 1996-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado, CA, US

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.