OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR— 510(k) K913559

Name: FDA 510(k) clearance K913559
Creator: U.S. Food and Drug Administration
Published: 1991-11-07

Substantially Equivalent

Osteo AG

FDA 510(k) clearance K913559 for OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR, Substantially Equivalent on 1991-11-07. Applicant: Osteo AG. Device class: 1.

Clearance details

Applicant: Osteo AG
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1991-08-09
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood, SC, US

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K954080 — SODEM HIGH SPEED SYSTEM1995-10-16

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K922195 — OSTEO FEMORAL NAIL1992-07-23
K922196 — OSTEO TIBIA NAIL1992-07-23

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