TRACER DYNAMIC AXIAL FIXATION— 510(k) K892638

Substantially Equivalent

Tracer Medical

FDA 510(k) clearance K892638 for TRACER DYNAMIC AXIAL FIXATION, Substantially Equivalent on 1989-08-11. Applicant: Tracer Medical. Device class: 2.

Clearance details

Applicant: Tracer Medical
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1989-04-12
Decision date: 1989-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Paula, CA, 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.