GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 Head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 Mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6

Plate, Fixation, Bone

GPC Medical Limited

The following data is part of a premarket notification filed by Gpc Medical Limited with the FDA for Gpc 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 Head Holes, Gpc 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 Mm Variable Angle Locking Two Column Volar Distal Radius Plate-narrow, 6 .

Pre-market Notification Details

Device IDK210198
510k NumberK210198
Device Name:GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 Head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 Mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6
ClassificationPlate, Fixation, Bone
Applicant GPC Medical Limited GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi,  IN 110018
ContactVikas Narang
CorrespondentVikas Narang
GPC Medical Limited GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi,  IN 110018
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2022-01-07

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