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510(k) K112484

ZAVATION SPINAL SYSTEM by Zavation, LLC — Product Code MNI

K112484 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 November 22, 2011. The device falls under product code MNI (Orthosis, Spinal Pedicle 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
November 22, 2011
Date Received
August 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle 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)
  • K153404 — Zavation Spinal System (April 21, 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)

Other clearances for product code MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)

FDA data resources