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510(k) K160362

Z-Span Plate System by Zavation, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2016
Date Received
February 9, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Zavation, LLC

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  • K161016 — Z-Clamp ISP System (October 19, 2016)
  • K153404 — Zavation Spinal System (April 21, 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)

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