The following data is part of a premarket notification filed by Ortho Solutions Uk Ltd with the FDA for Volition Plating System.
| Device ID | K210658 |
| 510k Number | K210658 |
| Device Name: | Volition Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Ortho Solutions UK Ltd West Station Business Park, Spital Road Maldon, GB CMF 6FF |
| Contact | Andy Leither |
| Correspondent | Andy Leither Ortho Solutions UK Ltd West Station Business Park, Spital Road Maldon, GB CMF 6FF |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-04 |
| Decision Date | 2021-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055662968187 | K210658 | 000 |
| 05055662966992 | K210658 | 000 |
| 05055662967005 | K210658 | 000 |
| 05055662967012 | K210658 | 000 |
| 05055662967029 | K210658 | 000 |
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| 05055662967050 | K210658 | 000 |
| 05055662967067 | K210658 | 000 |
| 05055662966985 | K210658 | 000 |
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