The following data is part of a premarket notification filed by Solana Surgical Llc with the FDA for Solafix Twist Screw Implant System, Surgical Instrument Set.
| Device ID | K120390 |
| 510k Number | K120390 |
| Device Name: | SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET |
| Classification | Screw, Fixation, Bone |
| Applicant | SOLANA SURGICAL LLC 6363 POPLAR AVE SUITE 434 Memphis, TN 38119 |
| Contact | Louise Rocht |
| Correspondent | Louise Rocht SOLANA SURGICAL LLC 6363 POPLAR AVE SUITE 434 Memphis, TN 38119 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-07 |
| Decision Date | 2012-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420168115 | K120390 | 000 |
| 00840420168108 | K120390 | 000 |
| 00840420168092 | K120390 | 000 |
| 00840420168085 | K120390 | 000 |
| 00840420168078 | K120390 | 000 |
| 00840420168061 | K120390 | 000 |