The following data is part of a premarket notification filed by Solana Surgical Llc with the FDA for Metatarsal Decompression Implant, Model 100.
| Device ID | K090127 |
| 510k Number | K090127 |
| Device Name: | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | SOLANA SURGICAL LLC 1828 BAILEY DRIVE Oceanside, CA 92056 |
| Contact | Bruce Lawrence |
| Correspondent | Bruce Lawrence SOLANA SURGICAL LLC 1828 BAILEY DRIVE Oceanside, CA 92056 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420150875 | K090127 | 000 |
| 00840420150868 | K090127 | 000 |
| 00840420150851 | K090127 | 000 |
| 00840420150844 | K090127 | 000 |