DVR® Crosslock Wrist Spanning Plate (131849181)

Plate, Fixation, Bone

Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc D.b.a Resolve Surgical Tech with the FDA for Dvr® Crosslock Wrist Spanning Plate (131849181).

Pre-market Notification Details

Device IDK220244
510k NumberK220244
Device Name:DVR® Crosslock Wrist Spanning Plate (131849181)
ClassificationPlate, Fixation, Bone
Applicant Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech 375 River Park Circle Marquette,  MI  49855
ContactJaclyn Holli
CorrespondentJaclyn Holli
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech 375 River Park Circle Marquette,  MI  49855
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-28
Decision Date2022-04-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00846468005108 K220244 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.