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510(k) K940631

CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM by Cross Medical Products, Inc. — Product Code MNH

K940631 is an FDA 510(k) premarket notification submitted by Cross Medical Products, Inc. for the device "CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM". The FDA issued a decision of SN on July 13, 1995. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Cross Medical Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 13, 1995
Date Received
February 14, 1994
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)
  • 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)
  • 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)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)

FDA data resources