510(k) K231447
K231447 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Double Internal Joint Stabilizer- Elbow". The FDA issued a decision of Substantially Equivalent on December 15, 2023. The device falls under product code OZI (Internal Hinged Elbow Fixator), a Class II device regulated under 21 CFR 888.3030. Skeletal Dynamics, Inc. has at least 10 other 510(k) clearances on record.
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.