The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for Hammer Toe Implant.
| Device ID | K122959 |
| 510k Number | K122959 |
| Device Name: | HAMMER TOE 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 | 2012-09-25 |
| Decision Date | 2012-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926022215 | K122959 | 000 |
| 00812926022055 | K122959 | 000 |
| 00812926022048 | K122959 | 000 |
| 00812926022031 | K122959 | 000 |
| 00812926022024 | K122959 | 000 |
| 00812926022017 | K122959 | 000 |
| 00812926022000 | K122959 | 000 |
| 00812926021997 | K122959 | 000 |
| 00812926021980 | K122959 | 000 |
| 00812926021973 | K122959 | 000 |
| 00812926021966 | K122959 | 000 |
| 00812926021959 | K122959 | 000 |
| 00812926021942 | K122959 | 000 |
| 00812926022062 | K122959 | 000 |
| 00812926022079 | K122959 | 000 |
| 00812926022086 | K122959 | 000 |
| 00812926022208 | K122959 | 000 |
| 00812926022192 | K122959 | 000 |
| 00812926022185 | K122959 | 000 |
| 00812926022178 | K122959 | 000 |
| 00812926022161 | K122959 | 000 |
| 00812926022154 | K122959 | 000 |
| 00812926022147 | K122959 | 000 |
| 00812926022130 | K122959 | 000 |
| 00812926022123 | K122959 | 000 |
| 00812926022116 | K122959 | 000 |
| 00812926022109 | K122959 | 000 |
| 00812926022093 | K122959 | 000 |
| 00812926021935 | K122959 | 000 |