SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR— 510(k) K950384

Name: FDA 510(k) clearance K950384
Creator: U.S. Food and Drug Administration
Published: 1995-05-22

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K950384 for SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR, Substantially Equivalent on 1995-05-22. Applicant: Synthes (Usa). Device class: 2.

Clearance details

Applicant: Synthes (Usa)
Product code: Code LXT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1995-02-01
Decision date: 1995-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.