The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Maxlock Extreme Extremity Plating System Distal Radius Plates And Screws.
| Device ID | K102156 |
| 510k Number | K102156 |
| Device Name: | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina, OH 44256 |
| Contact | Derek Lewis |
| Correspondent | Derek Lewis ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina, OH 44256 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2010-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832058402 | K102156 | 000 |
| 00846832031498 | K102156 | 000 |
| 00846832031245 | K102156 | 000 |
| 00846832031238 | K102156 | 000 |
| 00846832031221 | K102156 | 000 |
| 00846832031214 | K102156 | 000 |
| 00846832031207 | K102156 | 000 |
| 00846832031191 | K102156 | 000 |
| 00846832031184 | K102156 | 000 |
| 00846832031504 | K102156 | 000 |
| 00846832031511 | K102156 | 000 |
| 00846832031528 | K102156 | 000 |
| 00846832058396 | K102156 | 000 |
| 00846832031597 | K102156 | 000 |
| 00846832031580 | K102156 | 000 |
| 00846832031573 | K102156 | 000 |
| 00846832031566 | K102156 | 000 |
| 00846832031559 | K102156 | 000 |
| 00846832031542 | K102156 | 000 |
| 00846832031535 | K102156 | 000 |
| 00846832031177 | K102156 | 000 |