510(k) K220244

DVR® Crosslock Wrist Spanning Plate (131849181) by Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech — Product Code HRS

K220244 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech for the device "DVR® Crosslock Wrist Spanning Plate (131849181)". The FDA issued a decision of Substantially Equivalent on April 28, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2022
Date Received
January 28, 2022
Clearance Type
Traditional
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