The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed External Fixation Device.
| Device ID | K061759 |
| 510k Number | K061759 |
| Device Name: | REPROCESSED EXTERNAL FIXATION DEVICE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-22 |
| Decision Date | 2006-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825020361 | K061759 | 000 |
| 00885825020231 | K061759 | 000 |
| 00885825020224 | K061759 | 000 |
| 00885825020217 | K061759 | 000 |
| 00885825020200 | K061759 | 000 |
| 00885825020194 | K061759 | 000 |
| 00885825020187 | K061759 | 000 |
| 00885825020170 | K061759 | 000 |
| 00885825020163 | K061759 | 000 |
| 00885825020156 | K061759 | 000 |
| 00885825020248 | K061759 | 000 |
| 00885825020255 | K061759 | 000 |
| 00885825020262 | K061759 | 000 |
| 00885825020354 | K061759 | 000 |
| 00885825020347 | K061759 | 000 |
| 00885825020330 | K061759 | 000 |
| 00885825020323 | K061759 | 000 |
| 00885825020316 | K061759 | 000 |
| 00885825020309 | K061759 | 000 |
| 00885825020293 | K061759 | 000 |
| 00885825020286 | K061759 | 000 |
| 00885825020279 | K061759 | 000 |
| 00885825020149 | K061759 | 000 |