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510(k) K991064

METACARPAL FIXATION SYSTEM by Medcanica, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1999
Date Received
March 31, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Medcanica, Inc.

  • K011373 — INSTRUMENT DAMPING PORT (October 12, 2001)
  • K011349 — INTERCOSTAL LOCKABLE-DIRECTABLE PORT (October 5, 2001)
  • K994232 — PHALANGEAL FIXATION SYSTEM (March 1, 2000)
  • K991486 — ULTRA-CBX (November 5, 1999)

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