The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for Trilliant Surgical K-wires.
| Device ID | K121008 |
| 510k Number | K121008 |
| Device Name: | TRILLIANT SURGICAL K-WIRES |
| Classification | Pin, Fixation, Smooth |
| Applicant | TRILLIANT SURGICAL LTD 6721 Portwest Dr Ste 160 Houston, TX 77024 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb TRILLIANT SURGICAL LTD 6721 Portwest Dr Ste 160 Houston, TX 77024 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-03 |
| Decision Date | 2012-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926027838 | K121008 | 000 |
| 00812926022352 | K121008 | 000 |
| 00812926022390 | K121008 | 000 |
| 00812926022406 | K121008 | 000 |
| 00812926023946 | K121008 | 000 |
| 00812926023953 | K121008 | 000 |
| 00812926023960 | K121008 | 000 |
| 00812926027128 | K121008 | 000 |
| 00812926027821 | K121008 | 000 |
| 00812926022345 | K121008 | 000 |