The following data is part of a premarket notification filed by Solana Surgical, Llc with the FDA for Fuseforce Implant System.
| Device ID | K124045 |
| 510k Number | K124045 |
| Device Name: | FUSEFORCE IMPLANT SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | SOLANA SURGICAL, LLC 6363 POPLAR AVENUE SUITE 312 Memphis, TN 38119 |
| Contact | Joe Clift |
| Correspondent | Joe Clift SOLANA SURGICAL, LLC 6363 POPLAR AVENUE SUITE 312 Memphis, TN 38119 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-31 |
| Decision Date | 2013-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420168023 | K124045 | 000 |
| 00840420167750 | K124045 | 000 |
| 00840420167736 | K124045 | 000 |
| 00840420167729 | K124045 | 000 |
| 00840420127396 | K124045 | 000 |
| 00840420127389 | K124045 | 000 |
| 00840420127372 | K124045 | 000 |
| 00840420127365 | K124045 | 000 |
| 00840420127358 | K124045 | 000 |
| 00840420127341 | K124045 | 000 |
| 00840420127334 | K124045 | 000 |
| 00840420127327 | K124045 | 000 |
| 00840420167767 | K124045 | 000 |
| 00840420167781 | K124045 | 000 |
| 00840420168016 | K124045 | 000 |
| 00840420168009 | K124045 | 000 |
| 00840420167996 | K124045 | 000 |
| 00840420167989 | K124045 | 000 |
| 00840420167972 | K124045 | 000 |
| 00840420167965 | K124045 | 000 |
| 00840420167958 | K124045 | 000 |
| 00840420167941 | K124045 | 000 |
| 00840420167934 | K124045 | 000 |
| 00840420167927 | K124045 | 000 |
| 00840420167804 | K124045 | 000 |
| 00840420127310 | K124045 | 000 |