The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Maxlock Extreme System Model Mxl.
| Device ID | K123203 |
| 510k Number | K123203 |
| Device Name: | MAXLOCK EXTREME SYSTEM MODEL MXL |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-12 |
| Decision Date | 2012-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832054022 | K123203 | 000 |
| 00846832039159 | K123203 | 000 |
| 00846832039142 | K123203 | 000 |
| 00846832039135 | K123203 | 000 |
| 00846832039128 | K123203 | 000 |
| 00846832039111 | K123203 | 000 |
| 00846832039104 | K123203 | 000 |
| 00846832039098 | K123203 | 000 |
| 00846832039081 | K123203 | 000 |
| 00846832039074 | K123203 | 000 |
| 00846832039067 | K123203 | 000 |
| 00846832027095 | K123203 | 000 |
| 00846832039166 | K123203 | 000 |
| 00846832039173 | K123203 | 000 |
| 00846832054015 | K123203 | 000 |
| 00846832053995 | K123203 | 000 |
| 00846832053988 | K123203 | 000 |
| 00846832053629 | K123203 | 000 |
| 00846832053612 | K123203 | 000 |
| 00846832053605 | K123203 | 000 |
| 00846832053599 | K123203 | 000 |
| 00846832039210 | K123203 | 000 |
| 00846832039203 | K123203 | 000 |
| 00846832039197 | K123203 | 000 |
| 00846832039180 | K123203 | 000 |
| 00846832027071 | K123203 | 000 |