The following data is part of a premarket notification filed by Alliance Medical, Inc. with the FDA for Reprocessed External Fixation Device.
| Device ID | K012634 |
| 510k Number | K012634 |
| Device Name: | REPROCESSED EXTERNAL FIXATION DEVICE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. Phoenix, AZ 85044 |
| Contact | Don Selvey |
| Correspondent | Don Selvey ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. Phoenix, AZ 85044 |
| Product Code | KTW |
| Subsequent Product Code | JEC |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2002-06-24 |
| Summary: | summary |