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510(k) K003384

VERSALINK TITANIUM ROD-TO-ROD COUPLERS by Osteotech, Inc. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2000
Date Received
October 31, 2000
Clearance Type
Special
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 Osteotech, Inc.

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  • K080511 — PLEXUR-P (April 21, 2008)
  • K073405 — PLEXUR M (March 3, 2008)
  • K061982 — PLEXUR P (February 7, 2007)
  • K051188 — GRAFTON DBM (January 3, 2006)
  • K051781 — GRAFTCAGE TLX (December 16, 2005)
  • K051195 — GRAFTON DBM (December 16, 2005)
  • K043209 — VIAGRAF DBM PASTE (December 5, 2005)
  • K053080 — GRAFTCAGE ACX (December 1, 2005)

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)