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510(k) K242650

zLOCK Lumbar Facet Fixation System by Zygofix , Ltd. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
September 4, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Facet Screw Spinal Device
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Zygofix , Ltd.

  • K240085 — zLOCK Lumbar Facet Fixation System (April 18, 2024)

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