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510(k) K133556

VIRAGE OCT SPINAL FIXATION SYSTEM by Zimmer Spine, Inc. — Product Code KWP

K133556 is an FDA 510(k) premarket notification submitted by Zimmer Spine, Inc. for the device "VIRAGE OCT SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 2014. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Zimmer Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2014
Date Received
November 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Zimmer Spine, Inc.

  • K153631 — Zimmer Virage OCT Spinal Fixation System (February 16, 2016)
  • K150896 — Vitality Spinal Fixation System (August 31, 2015)
  • K151031 — Virage OCT Spinal Fixation System (June 24, 2015)
  • K142752 — Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation Syst (June 18, 2015)
  • K143626 — inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plati (March 20, 2015)
  • K143297 — Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Int (February 12, 2015)
  • K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (October 29, 2014)
  • K141500 — OPTIO-C ANTERIOR CERVICAL SYSTEM (September 23, 2014)
  • K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM (May 21, 2014)
  • K133184 — ARDIS INTERBODY SYSTEM (January 30, 2014)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources