SYNTHES AFS— 510(k) K032534

Substantially Equivalent

Synthes Spine

FDA 510(k) clearance K032534 for SYNTHES AFS, Substantially Equivalent on 2004-04-01. Applicant: Synthes Spine. Device class: 2.

Clearance details

Applicant: Synthes Spine
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2003-08-15
Decision date: 2004-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, 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.