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510(k) K223318

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2023
Date Received
October 28, 2022
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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  • K231447 — Double Internal Joint Stabilizer- Elbow (December 15, 2023)
  • K231188 — ALIGN Radial Head System (September 28, 2023)
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Other clearances for product code OZI

  • K231447 — Double Internal Joint Stabilizer- Elbow (December 15, 2023)
  • K153208 — Internal Joint Stabilizer - Elbow (December 31, 2015)