510(k) K230764
K230764 is an FDA 510(k) premarket notification submitted by OsteoCentric Technologies for the device "OsteoCentric Integrated Hip Fastener System". The FDA issued a decision of Substantially Equivalent on April 18, 2023. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. OsteoCentric Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2023
- Date Received
- March 20, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Proximal Femoral, Implant
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type