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 |