The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Maxlock Extreme System.
| Device ID | K132591 |
| 510k Number | K132591 |
| Device Name: | MAXLOCK EXTREME SYSTEM |
| 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 | 2013-08-19 |
| Decision Date | 2013-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832039609 | K132591 | 000 |
| 00846832039593 | K132591 | 000 |
| 00846832032648 | K132591 | 000 |