The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Universal Total Wrist System.
| Device ID | K030037 |
| 510k Number | K030037 |
| Device Name: | UNIVERSAL TOTAL WRIST SYSTEM |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Applicant | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Contact | John Spampinato |
| Correspondent | John Spampinato KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Product Code | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-06 |
| Decision Date | 2003-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556864913 | K030037 | 000 |
| 00885556865118 | K030037 | 000 |
| 00885556865545 | K030037 | 000 |
| 00885556865552 | K030037 | 000 |
| 00885556865569 | K030037 | 000 |
| 00885556865576 | K030037 | 000 |
| 00885556865583 | K030037 | 000 |
| 00885556865590 | K030037 | 000 |
| 00885556865606 | K030037 | 000 |
| 00885556865613 | K030037 | 000 |
| 00885556865620 | K030037 | 000 |
| 00885556865637 | K030037 | 000 |
| 00885556865644 | K030037 | 000 |
| 00885556865651 | K030037 | 000 |
| 00885556865668 | K030037 | 000 |
| M2482645151 | K030037 | 000 |
| M2482645251 | K030037 | 000 |
| M248264515S1 | K030037 | 000 |
| 00885556865101 | K030037 | 000 |
| 00885556865095 | K030037 | 000 |
| 00885556864920 | K030037 | 000 |
| 00885556864937 | K030037 | 000 |
| 00885556864944 | K030037 | 000 |
| 00885556864951 | K030037 | 000 |
| 00885556864968 | K030037 | 000 |
| 00885556864975 | K030037 | 000 |
| 00885556864982 | K030037 | 000 |
| 00885556864999 | K030037 | 000 |
| 00885556865002 | K030037 | 000 |
| 00885556865019 | K030037 | 000 |
| 00885556865026 | K030037 | 000 |
| 00885556865033 | K030037 | 000 |
| 00885556865040 | K030037 | 000 |
| 00885556865057 | K030037 | 000 |
| 00885556865064 | K030037 | 000 |
| 00885556865071 | K030037 | 000 |
| 00885556865088 | K030037 | 000 |
| M2482645201 | K030037 | 000 |
| M2482645301 | K030037 | 000 |
| M2482645351 | K030037 | 000 |
| M248263200RT1 | K030037 | 000 |
| M248263300LF1 | K030037 | 000 |
| M248263300RT1 | K030037 | 000 |
| M248263400LF1 | K030037 | 000 |
| M248263400RT1 | K030037 | 000 |
| M268263500LF1 | K030037 | 000 |
| M268263500RT1 | K030037 | 000 |
| M268263600LF1 | K030037 | 000 |
| M268263600RT1 | K030037 | 000 |
| M268263700LF1 | K030037 | 000 |
| M268263700RT1 | K030037 | 000 |
| M268263800LF1 | K030037 | 000 |
| M268263800RT1 | K030037 | 000 |
| M248264520S1 | K030037 | 000 |
| M248264525S1 | K030037 | 000 |
| M248264530S1 | K030037 | 000 |
| M248264535S1 | K030037 | 000 |
| M248263200LF1 | K030037 | 000 |
| M248263100RT1 | K030037 | 000 |
| M2482611011 | K030037 | 000 |
| M2482612011 | K030037 | 000 |
| M2482613011 | K030037 | 000 |
| M2482614011 | K030037 | 000 |
| M2482621001 | K030037 | 000 |
| M2482621011 | K030037 | 000 |
| M2482621021 | K030037 | 000 |
| M2482622001 | K030037 | 000 |
| M2482622011 | K030037 | 000 |
| M2482622021 | K030037 | 000 |
| M2482623001 | K030037 | 000 |
| M2482623011 | K030037 | 000 |
| M2482623021 | K030037 | 000 |
| M2482624001 | K030037 | 000 |
| M2482624011 | K030037 | 000 |
| M2482624021 | K030037 | 000 |
| M248263100LF1 | K030037 | 000 |
| M268UNI2SET0 | K030037 | 000 |