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510(k) K153404

Zavation Spinal System by Zavation, LLC — Product Code MNH

K153404 is an FDA 510(k) premarket notification submitted by Zavation, LLC for the device "Zavation Spinal System". The FDA issued a decision of Substantially Equivalent on April 21, 2016. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Zavation, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2016
Date Received
November 24, 2015
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 Zavation, LLC

  • K162206 — Zavation IBF (April 4, 2017)
  • K162575 — Z-LINKPC System (March 3, 2017)
  • K162824 — Z-Span Plate System (February 17, 2017)
  • K161016 — Z-Clamp ISP System (October 19, 2016)
  • K160362 — Z-Span Plate System (March 22, 2016)
  • K142392 — Zavation Posterior LEIF (April 29, 2015)
  • K142271 — Zavation Z-Link Lumbar (December 19, 2014)
  • K141419 — ZVPLASTY (September 12, 2014)
  • K141005 — Z-LINK CERVICAL (August 7, 2014)
  • K130030 — ZAVATION CERVICAL PLATE SYSTEM (April 25, 2013)

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)
  • 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)
  • K151116 — CapLOX II/TowerLOX Pedicle Screw System (June 26, 2015)

FDA data resources