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 |