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 .
| Device ID | K210198 |
| 510k Number | K210198 |
| 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 |
| Classification | Plate, Fixation, Bone |
| Applicant | GPC Medical Limited GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi, IN 110018 |
| Contact | Vikas Narang |
| Correspondent | Vikas Narang GPC Medical Limited GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi, IN 110018 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2022-01-07 |