The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Maxlock Extreme Extremity Plating System With Variable Angle Technology.
| Device ID | K100618 |
| 510k Number | K100618 |
| Device Name: | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY |
| 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 | 2010-03-04 |
| Decision Date | 2010-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832057627 | K100618 | 000 |
| 00846832057429 | K100618 | 000 |
| 00846832057412 | K100618 | 000 |
| 00846832057405 | K100618 | 000 |
| 00846832057399 | K100618 | 000 |
| 00846832057382 | K100618 | 000 |
| 00846832057375 | K100618 | 000 |
| 00846832054121 | K100618 | 000 |
| 00846832054107 | K100618 | 000 |
| 00846832032600 | K100618 | 000 |
| 00846832032594 | K100618 | 000 |
| 00846832032587 | K100618 | 000 |
| 00846832032570 | K100618 | 000 |
| 00846832032563 | K100618 | 000 |
| 00846832057436 | K100618 | 000 |
| 00846832057443 | K100618 | 000 |
| 00846832057573 | K100618 | 000 |
| 00846832057566 | K100618 | 000 |
| 00846832057559 | K100618 | 000 |
| 00846832057542 | K100618 | 000 |
| 00846832057535 | K100618 | 000 |
| 00846832057528 | K100618 | 000 |
| 00846832057511 | K100618 | 000 |
| 00846832057504 | K100618 | 000 |
| 00846832057498 | K100618 | 000 |
| 00846832057481 | K100618 | 000 |
| 00846832057474 | K100618 | 000 |
| 00846832057467 | K100618 | 000 |
| 00846832057450 | K100618 | 000 |
| 00846832032556 | K100618 | 000 |