K210198 is an FDA 510(k) clearance for the 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 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Gpc Medical Limited (New Delhi, IN). The FDA issued a Cleared decision on January 7, 2022, 347 days after receiving the submission on January 25, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K210198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 347 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS - Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |