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510(k) K241927

Synthes Graphic Case & Tray System by Synthes GmbH — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2025
Date Received
July 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • K122455 — SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM (April 11, 2013)
  • K122647 — SYNTHES PATIENT SPECIFIC PLATE (February 28, 2013)

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