The following data is part of a premarket notification filed by Solana Surgical, Llc with the FDA for Lesser Metatarsal Head Implant System.
| Device ID | K131187 |
| 510k Number | K131187 |
| Device Name: | LESSER METATARSAL HEAD IMPLANT SYSTEM |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| 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 | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2013-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420172211 | K131187 | 000 |
| 00840420172204 | K131187 | 000 |
| 00840420172198 | K131187 | 000 |
| 00840420168054 | K131187 | 000 |
| 00840420168047 | K131187 | 000 |
| 00840420168030 | K131187 | 000 |