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510(k) K231447

Double Internal Joint Stabilizer- Elbow by Skeletal Dynamics, Inc. — Product Code OZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
May 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Internal Hinged Elbow Fixator
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.

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  • K231623 — Distal Elbow Plating System (August 28, 2023)
  • K223318 — Internal Joint Stabilizer - Elbow (May 10, 2023)

Other clearances for product code OZI

  • K223318 — Internal Joint Stabilizer - Elbow (May 10, 2023)
  • K153208 — Internal Joint Stabilizer - Elbow (December 31, 2015)