The following data is part of a premarket notification filed by Solana Surgical Llc with the FDA for Metatarsal Decompression Implant Surgical Instrument Set.
Device ID | K113752 |
510k Number | K113752 |
Device Name: | METATARSAL DECOMPRESSION 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 | 2011-12-21 |
Decision Date | 2012-02-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840420173201 | K113752 | 000 |
00840420173195 | K113752 | 000 |
00840420173188 | K113752 | 000 |
00840420173171 | K113752 | 000 |