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510(k) K081331

FIXXSURE CROSS LINK by Spineworks, LLC — Product Code MNH

K081331 is an FDA 510(k) premarket notification submitted by Spineworks, LLC for the device "FIXXSURE CROSS LINK". The FDA issued a decision of Substantially Equivalent on July 23, 2008. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Spineworks, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2008
Date Received
May 12, 2008
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 Spineworks, LLC

  • K133340 — SPINEWORKS ANTERIOR LUMBAR DEVICE (April 11, 2014)
  • K111166 — A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) (September 8, 2011)
  • K042600 — STANSION MATRIX (February 18, 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)

FDA data resources