510(k) K223318
K223318 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Internal Joint Stabilizer - Elbow". The FDA issued a decision of Substantially Equivalent on May 10, 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
- 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.