The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Clavicle Plating System.
| Device ID | K090289 |
| 510k Number | K090289 |
| Device Name: | CLAVICLE PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 1815 W. MARKET ST. SUITE 205 Akron, OH 44313 |
| Contact | Derek Lewis |
| Correspondent | Derek Lewis ORTHOHELIX SURGICAL DESIGNS, INC. 1815 W. MARKET ST. SUITE 205 Akron, OH 44313 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-05 |
| Decision Date | 2009-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832028368 | K090289 | 000 |
| 00846832028290 | K090289 | 000 |
| 00846832028283 | K090289 | 000 |
| 00846832028276 | K090289 | 000 |
| 00846832028269 | K090289 | 000 |
| 00846832028252 | K090289 | 000 |