The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Metal Great Toe System.
| Device ID | K092047 |
| 510k Number | K092047 |
| Device Name: | ASCENSION METAL GREAT TOE SYSTEM |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Contact | Debbie Stearns |
| Correspondent | Debbie Stearns ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2010-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780116462 | K092047 | 000 |
| 00885556828403 | K092047 | 000 |
| 00885556828397 | K092047 | 000 |
| 00885556828359 | K092047 | 000 |
| 00885556828328 | K092047 | 000 |
| 00885556828304 | K092047 | 000 |
| 00885556828298 | K092047 | 000 |
| 00885556828274 | K092047 | 000 |
| 00885556828267 | K092047 | 000 |
| 00885556828243 | K092047 | 000 |
| 00885556828236 | K092047 | 000 |
| 00885556828212 | K092047 | 000 |
| 00885556828427 | K092047 | 000 |
| 00885556828434 | K092047 | 000 |
| 00885556828458 | K092047 | 000 |
| 10381780116448 | K092047 | 000 |
| 10381780116424 | K092047 | 000 |
| 10381780116400 | K092047 | 000 |
| 10381780116479 | K092047 | 000 |
| 10381780116455 | K092047 | 000 |
| 10381780116431 | K092047 | 000 |
| 10381780116417 | K092047 | 000 |
| M268MOVEMNTINSTP1 | K092047 | 000 |
| 00885556828496 | K092047 | 000 |
| 00885556828489 | K092047 | 000 |
| 00885556828465 | K092047 | 000 |
| 00885556828205 | K092047 | 000 |