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510(k) K203218

CaP Spheres Pellet Pack by Zimmer Biomet Spine, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
November 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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  • 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)
  • K181096 — Avenue P Cage System (January 15, 2019)
  • K180227 — Polaris Spinal Growth System (March 15, 2018)

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