The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for Trilliant Surgical Subtalar Implant.
| Device ID | K103183 |
| 510k Number | K103183 |
| Device Name: | TRILLIANT SURGICAL SUBTALAR IMPLANT |
| Classification | Screw, Fixation, Bone |
| Applicant | TRILLIANT SURGICAL LTD 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb TRILLIANT SURGICAL LTD 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-28 |
| Decision Date | 2011-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926020389 | K103183 | 000 |
| 00812926020280 | K103183 | 000 |
| 00812926020273 | K103183 | 000 |
| 00812926020266 | K103183 | 000 |
| 00812926020259 | K103183 | 000 |
| 00812926020242 | K103183 | 000 |
| 00812926020235 | K103183 | 000 |