510(k) K242995

OIC Small / Mini Fragment Plate System by The Orthopaedic Implant Company — Product Code HRS

K242995 is an FDA 510(k) premarket notification submitted by The Orthopaedic Implant Company for the device "OIC Small / Mini Fragment Plate System". The FDA issued a decision of Substantially Equivalent on October 23, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. The Orthopaedic Implant Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2024
Date Received
September 26, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type