The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for 3s Hemi Toe.
| Device ID | K072922 |
| 510k Number | K072922 |
| Device Name: | 3S HEMI TOE |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | TRILLIANT SURGICAL LTD 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | Jd Webb |
| Correspondent | Jd Webb TRILLIANT SURGICAL LTD 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-15 |
| Decision Date | 2007-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926020105 | K072922 | 000 |
| 00812926020099 | K072922 | 000 |
| 00812926020082 | K072922 | 000 |
| 00812926020075 | K072922 | 000 |