510(k) K221090

Metal Cannulated Screw by Double Medical Technology, Inc. — Product Code HWC

K221090 is an FDA 510(k) premarket notification submitted by Double Medical Technology, Inc. for the device "Metal Cannulated Screw". The FDA issued a decision of Substantially Equivalent on January 10, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Double Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2023
Date Received
April 13, 2022
Clearance Type
Traditional
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