The following data is part of a premarket notification filed by Solana Surgical Llc with the FDA for Hemi Phalangeal Implant Surgical Instrument Set.
| Device ID | K120029 |
| 510k Number | K120029 |
| Device Name: | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | SOLANA SURGICAL LLC 6363 POPLAR AVE SUITE 434 Memphis, TN 38119 |
| Contact | Louise Focht |
| Correspondent | Louise Focht SOLANA SURGICAL LLC 6363 POPLAR AVE SUITE 434 Memphis, TN 38119 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-04 |
| Decision Date | 2012-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420169396 | K120029 | 000 |
| 00840420169389 | K120029 | 000 |
| 00840420169372 | K120029 | 000 |
| 00840420169303 | K120029 | 000 |
| 00840420169297 | K120029 | 000 |
| 00840420169280 | K120029 | 000 |