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510(k) K973836

SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM by Cross Medical Products, Inc. — Product Code MNH

Clearance Details

Decision
SN ()
Decision Date
March 5, 1998
Date Received
October 8, 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.

  • K974749 — SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY A (March 13, 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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