510(k) K230764

OsteoCentric Integrated Hip Fastener System by OsteoCentric Technologies — Product Code JDO

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 Apr 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
Apr 18, 2023
Date Received
Mar 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