The following data is part of a premarket notification filed by Allez Spine, Llc with the FDA for Allez Spine Cross Connectors.
Device ID | K070460 |
510k Number | K070460 |
Device Name: | ALLEZ SPINE CROSS CONNECTORS |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | ALLEZ SPINE, LLC 2301 DUPONT DRIVE, SUITE 510 Irvine, CA 92612 |
Contact | Hartmut Loch |
Correspondent | Hartmut Loch ALLEZ SPINE, LLC 2301 DUPONT DRIVE, SUITE 510 Irvine, CA 92612 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
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 | 2007-02-16 |
Decision Date | 2007-06-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844856074279 | K070460 | 000 |
00844856074262 | K070460 | 000 |
00844856074255 | K070460 | 000 |