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510(k) K142053

UNIVERSAL CLAMP SPINAL FIXATION SYSTEM by Zimmer Spine, Inc. — Product Code OWI

K142053 is an FDA 510(k) premarket notification submitted by Zimmer Spine, Inc. for the device "UNIVERSAL CLAMP SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 2014. The device falls under product code OWI (Bone Fixation Cerclage, Sublaminar), a Class II device regulated under 21 CFR 888.3010. Zimmer Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2014
Date Received
July 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Fixation Cerclage, Sublaminar
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

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)
  • K141500 — OPTIO-C ANTERIOR CERVICAL SYSTEM (September 23, 2014)
  • K133556 — VIRAGE OCT SPINAL FIXATION SYSTEM (June 2, 2014)
  • K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM (May 21, 2014)
  • K133184 — ARDIS INTERBODY SYSTEM (January 30, 2014)

Other clearances for product code OWI

  • K261374 — LigaPASS™ System (May 27, 2026)
  • K253615 — Invictus Bands System (March 25, 2026)
  • K222097 — OLYMPIC Deformity Band System (May 4, 2023)
  • K230565 — HILINE™ Fixation System (April 20, 2023)
  • K213659 — LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
  • K211057 — LigaPASS® Spinal System, CD Horizon™ Spinal System (May 27, 2021)
  • K201240 — Mariner Cap System (August 5, 2020)
  • K200281 — The Gecko Spinal System (March 31, 2020)
  • K200097 — Response BandLoc Spinal Fixation (March 16, 2020)
  • K191217 — JAZZ PF (August 2, 2019)

FDA data resources