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510(k) K931682

CANNULATED MALLEOLAR SCREW by Onyx Medical Corp. — Product Code KWK

K931682 is an FDA 510(k) premarket notification submitted by Onyx Medical Corp. for the device "CANNULATED MALLEOLAR SCREW". The FDA issued a decision of SN on April 5, 1994. The device falls under product code KWK (Appliance, Nail/Blade/Plate Combination, Single Component), a Class II device regulated under 21 CFR 888.3030. Onyx Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 5, 1994
Date Received
April 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Nail/Blade/Plate Combination, Single Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Onyx Medical Corp.

  • K041679 — COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT (December 16, 2004)
  • K942022 — FACE-IT SHIELD (July 8, 1994)
  • K931690 — SPOON PLATE (June 7, 1994)
  • K931680 — CANNULATED CANCELLOUS SCREW (May 4, 1994)
  • K934614 — MINI FRAGMENT PLATE (May 4, 1994)
  • K931692 — T-PLATE (May 4, 1994)
  • K931684 — EPIPHYSIS PLATE (May 4, 1994)
  • K931685 — FOREARM SELF COMPRESSION PLATE (April 25, 1994)
  • K931694 — 1/4 TUBULAR PLATE (April 25, 1994)
  • K931687 — MULTIPLE FRAGMENT PLATE (April 25, 1994)

FDA data resources