The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed External Fixation Device.
| Device ID | K012623 |
| 510k Number | K012623 |
| Device Name: | REPROCESSED EXTERNAL FIXATION DEVICE |
| 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 |
|---|---|---|
| 00885825020859 | K012623 | 000 |
| 00885825020668 | K012623 | 000 |
| 00885825020651 | K012623 | 000 |
| 00885825020644 | K012623 | 000 |
| 00885825020637 | K012623 | 000 |
| 00885825020620 | K012623 | 000 |
| 00885825020613 | K012623 | 000 |
| 00885825020606 | K012623 | 000 |
| 00885825020590 | K012623 | 000 |
| 00885825020583 | K012623 | 000 |
| 00885825020576 | K012623 | 000 |
| 00885825020682 | K012623 | 000 |
| 00885825020699 | K012623 | 000 |
| 00885825020798 | K012623 | 000 |
| 00885825020781 | K012623 | 000 |
| 00885825020774 | K012623 | 000 |
| 00885825020767 | K012623 | 000 |
| 00885825020750 | K012623 | 000 |
| 00885825020743 | K012623 | 000 |
| 00885825020736 | K012623 | 000 |
| 00885825020729 | K012623 | 000 |
| 00885825020712 | K012623 | 000 |
| 00885825020705 | K012623 | 000 |
| 00885825020569 | K012623 | 000 |