TEXAS SCOTTISH RITE EASY/LOCK FIXATOR— 510(k) K931578

Name: FDA 510(k) clearance K931578
Creator: U.S. Food and Drug Administration
Published: 1994-02-22

Substantially Equivalent

Applied Osteo Systems, Inc.

FDA 510(k) clearance K931578 for TEXAS SCOTTISH RITE EASY/LOCK FIXATOR, Substantially Equivalent on 1994-02-22. Applicant: Applied Osteo Systems, Inc.. Device class: 2.

Clearance details

Applicant: Applied Osteo Systems, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1993-03-30
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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