CANNULATED MALLEOLAR SCREW— 510(k) K931682

Name: FDA 510(k) clearance K931682
Creator: U.S. Food and Drug Administration
Published: 1994-04-05

Substantially Equivalent for Some Indications

Onyx Medical Corp.

FDA 510(k) clearance K931682 for CANNULATED MALLEOLAR SCREW, Substantially Equivalent for Some Indications on 1994-04-05. Applicant: Onyx Medical Corp.. Device class: 2.

Clearance details

Applicant: Onyx Medical Corp.
Product code: Code KWK
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1993-04-05
Decision date: 1994-04-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K942022 — FACE-IT SHIELD1994-07-08
K931690 — SPOON PLATE1994-06-07
K931680 — CANNULATED CANCELLOUS SCREW1994-05-04
K931684 — EPIPHYSIS PLATE1994-05-04
K931692 — T-PLATE1994-05-04

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