510(k) K153208
K153208 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, LLC for the device "Internal Joint Stabilizer - Elbow". The FDA issued a decision of Substantially Equivalent on Dec 31, 2015. The device falls under product code OZI (Internal Hinged Elbow Fixator), a Class II device regulated under 21 CFR 888.3030. Skeletal Dynamics, LLC has 39 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 31, 2015
- Date Received
- Nov 5, 2015
- 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
- 510(k)
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.