The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for Disco Subtalar Implant.
| Device ID | K111834 |
| 510k Number | K111834 |
| Device Name: | DISCO 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 | 2011-06-29 |
| Decision Date | 2011-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926020341 | K111834 | 000 |
| 00812926020334 | K111834 | 000 |
| 00812926020327 | K111834 | 000 |
| 00812926020310 | K111834 | 000 |
| 00812926020303 | K111834 | 000 |
| 00812926020297 | K111834 | 000 |