510(k) K202680

OsteoMed ExtremiFix Mini & Small Cannulated Screw System by Osteomed, LLC — Product Code HWC

K202680 is an FDA 510(k) premarket notification submitted by Osteomed, LLC for the device "OsteoMed ExtremiFix Mini & Small Cannulated Screw System". The FDA issued a decision of Substantially Equivalent on October 15, 2020. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Osteomed, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2020
Date Received
September 15, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type