The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Subtalar Mba System.
| Device ID | K960692 |
| 510k Number | K960692 |
| Device Name: | SUBTALAR MBA SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Contact | Mark G Urbanski |
| Correspondent | Mark G Urbanski KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-20 |
| Decision Date | 1996-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2480501121 | K960692 | 000 |
| M2480501101 | K960692 | 000 |
| M2480501091 | K960692 | 000 |
| M2480501081 | K960692 | 000 |
| M2480501061 | K960692 | 000 |
| M248MBAIMP1 | K960692 | 000 |