The following data is part of a premarket notification filed by Kronner Medical with the FDA for Kronner Colles-forearm External Fixation.
| Device ID | K871248 |
| 510k Number | K871248 |
| Device Name: | KRONNER COLLES-FOREARM EXTERNAL FIXATION |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | KRONNER MEDICAL 544 WEST UMPQUA SUITE 104 Roseburg, OR 97470 |
| Contact | Crystal Kronner |
| Correspondent | Crystal Kronner KRONNER MEDICAL 544 WEST UMPQUA SUITE 104 Roseburg, OR 97470 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-30 |
| Decision Date | 1987-06-03 |