The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for Orion Blade Plate For Tibial Osteotomy.
| Device ID | K901272 |
| 510k Number | K901272 |
| Device Name: | ORION BLADE PLATE FOR TIBIAL OSTEOTOMY |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis, IN 46250 |
| Contact | Kenneth Epling |
| Correspondent | Kenneth Epling MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis, IN 46250 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-19 |
| Decision Date | 1990-04-23 |