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510(k) K943474

CANNULATED BONE SCREW by Cohort Medical Products Group, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
July 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Cohort Medical Products Group, Inc.

  • K964975 — COHORT DISCECTOMY SYSTEMS (CDS) (February 24, 1997)
  • K950011 — COHORT(TM) ANTERIOR PLATE SYSTEM (APS) (November 6, 1995)
  • K943804 — BONE SCREW (December 8, 1994)
  • K943472 — COHORT AVB RETRACTOR SYSTEM (October 20, 1994)

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