The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Kinetik Great Toe System.
| Device ID | K924724 |
| 510k Number | K924724 |
| Device Name: | KINETIK GREAT TOE SYSTEM |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Contact | Glynnis Stone |
| Correspondent | Glynnis Stone KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Product Code | LZJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-21 |
| Decision Date | 1994-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2480120161 | K924724 | 000 |
| M2480120101 | K924724 | 000 |
| M248KGTISET1 | K924724 | 000 |
| M2480120021 | K924724 | 000 |
| M2480120041 | K924724 | 000 |
| M2480120051 | K924724 | 000 |
| M2480120061 | K924724 | 000 |
| M2480120071 | K924724 | 000 |
| M2480120121 | K924724 | 000 |
| M2480120141 | K924724 | 000 |
| M2480120031 | K924724 | 000 |