510(k) K181096

Avenue P Cage System by Zimmer Biomet Spine, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 15, 2019
Date Received: April 26, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Zimmer Biomet Spine, Inc.

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K203218 — CaP Spheres Pellet Pack (May 4, 2021)
K210275 — Polaris Spinal System (April 2, 2021)
K203507 — Vitality® Spinal Fixation System (January 28, 2021)
K202309 — Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, (October 8, 2020)
K191722 — Vital Navigation System (December 2, 2019)
K192133 — Zimmer Biomet Universal Navigation System (October 29, 2019)
K190556 — Zimmer Biomet Universal Navigation System (October 24, 2019)
K183550 — Vitality® Spinal Fixation System (April 8, 2019)
K180227 — Polaris Spinal Growth System (March 15, 2018)

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