The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for K2 Hemi Toe Implant System (formerly Zobel Great Toe Implant System).
Device ID | K023770 |
510k Number | K023770 |
Device Name: | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) |
Classification | Prosthesis, Toe, Hemi-, Phalangeal |
Applicant | KINETIKOS MEDICAL, INC. 4115 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
Contact | John Spampinato |
Correspondent | John Spampinato KINETIKOS MEDICAL, INC. 4115 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
Product Code | KWD |
CFR Regulation Number | 888.3730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-12 |
Decision Date | 2002-12-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M248201040KMI1 | K023770 | 000 |
M2482010301 | K023770 | 000 |
M2482010201 | K023770 | 000 |
M2482010101 | K023770 | 000 |
M248HEMISET1 | K023770 | 000 |
M24820310041 | K023770 | 000 |