The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Mini Maxlock Extreme Plating System.
| Device ID | K121437 |
| 510k Number | K121437 |
| Device Name: | MINI MAXLOCK EXTREME PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256 |
| Contact | Derek Lewis |
| Correspondent | Derek Lewis ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. 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 | 2012-05-15 |
| Decision Date | 2012-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832054923 | K121437 | 000 |
| 00846832044924 | K121437 | 000 |
| 00846832044948 | K121437 | 000 |
| 00846832044955 | K121437 | 000 |
| 00846832044962 | K121437 | 000 |
| 00846832054886 | K121437 | 000 |
| 00846832054893 | K121437 | 000 |
| 00846832054909 | K121437 | 000 |
| 00846832054916 | K121437 | 000 |
| 00846832044726 | K121437 | 000 |