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510(k) K974749

SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS by Cross Medical Products, Inc. — Product Code MNH

Clearance Details

Decision
SN ()
Decision Date
March 13, 1998
Date Received
December 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Cross Medical Products, Inc.

  • 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)
  • K895587 — CROSS MEDICAL PRODUCT PEDICLE AWL (January 4, 1990)

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