The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Howmedica External Fixation Devices.
| Device ID | K012648 |
| 510k Number | K012648 |
| Device Name: | REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Don Selvey |
| Correspondent | Don Selvey ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | KTT |
| Subsequent Product Code | JEC |
| Subsequent Product Code | KTW |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825020842 | K012648 | 000 |
| 00885825020835 | K012648 | 000 |
| 00885825020828 | K012648 | 000 |
| 00885825020811 | K012648 | 000 |
| 00885825020804 | K012648 | 000 |
| 00885825020675 | K012648 | 000 |