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510(k) K895587

CROSS MEDICAL PRODUCT PEDICLE AWL by Cross Medical Products, Inc. — Product Code HWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
September 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Awl
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Cross Medical Products, Inc.

  • K974749 — SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY A (March 13, 1998)
  • K973836 — SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SY (March 5, 1998)
  • K950709 — SYNERGY TI ANTERIOR SPINAL SYSTEM (October 25, 1995)
  • K940631 — CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM (July 13, 1995)
  • K924381 — PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS (May 18, 1993)
  • K920116 — PWB LUMBOSACRAL SPINE SYSTEM (April 10, 1992)

Other clearances for product code HWJ

  • K880045 — ACROMED AWL/PUNCH, DEPTH GAUGE (February 17, 1988)
  • K875223 — DANNINGER ORTHOPAEDIC AWL (February 17, 1988)
  • K870779 — ACROMED WALLIE-HEINIG TROCHAR (March 9, 1987)