The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Modification To Reprocessed Synthes External Fixation Devices.
| Device ID | K032058 |
| 510k Number | K032058 |
| Device Name: | MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Moira Barton |
| Correspondent | Moira Barton ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-02 |
| Decision Date | 2003-07-30 |
| Summary: | summary |