The following data is part of a premarket notification filed by Genesys Spine with the FDA for Tilock Pedicle Screw System.
Device ID | K100757 |
510k Number | K100757 |
Device Name: | TILOCK PEDICLE SCREW SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
Contact | Josh Kaufmann |
Correspondent | Josh Kaufmann GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-17 |
Decision Date | 2010-07-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M719G1501050 | K100757 | 000 |
M719GL3130 | K100757 | 000 |
M719GL3120 | K100757 | 000 |
M719GL3100 | K100757 | 000 |
M719GL2240 | K100757 | 000 |
M719GL2220 | K100757 | 000 |
M719GL217NC0 | K100757 | 000 |
M719GL212NC0 | K100757 | 000 |
M719GL201TIB0 | K100757 | 000 |
M719G00020 | K100757 | 000 |
M719G00010 | K100757 | 000 |
M719G00000 | K100757 | 000 |
M71930051400 | K100757 | 000 |
M71930051300 | K100757 | 000 |
M719GL3150 | K100757 | 000 |
M719GL4210 | K100757 | 000 |
M719GLC4780 | K100757 | 000 |
M719GLC4660 | K100757 | 000 |
M719GLC4630 | K100757 | 000 |
M719GLC4620 | K100757 | 000 |
M719GLC46110 | K100757 | 000 |
M719GLC4600 | K100757 | 000 |
M719GLC4590 | K100757 | 000 |
M719GLC453R0 | K100757 | 000 |
M719GLC453L0 | K100757 | 000 |
M719GLC452R0 | K100757 | 000 |
M719GLC452L0 | K100757 | 000 |
M719GLC42510 | K100757 | 000 |
M719GLC409850 | K100757 | 000 |
M719SPGL2110 | K100757 | 000 |