The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Solanas Avalon Posterior Fixation System.
Device ID | K111076 |
510k Number | K111076 |
Device Name: | SOLANAS AVALON POSTERIOR FIXATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
Contact | Karla Schaffner |
Correspondent | Karla Schaffner ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-18 |
Decision Date | 2011-07-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844856074170 | K111076 | 000 |
00844856068827 | K111076 | 000 |
00844856068810 | K111076 | 000 |
00844856068803 | K111076 | 000 |
00844856068797 | K111076 | 000 |
00844856068780 | K111076 | 000 |
00844856068773 | K111076 | 000 |
00844856068766 | K111076 | 000 |
00844856068759 | K111076 | 000 |
00844856068735 | K111076 | 000 |
00844856068728 | K111076 | 000 |
00844856000001 | K111076 | 000 |
00844856068834 | K111076 | 000 |
00844856068841 | K111076 | 000 |
00844856068858 | K111076 | 000 |
00844856074163 | K111076 | 000 |
00844856074156 | K111076 | 000 |
00844856074149 | K111076 | 000 |
00844856074132 | K111076 | 000 |
00844856074125 | K111076 | 000 |
00844856074118 | K111076 | 000 |
00844856074101 | K111076 | 000 |
00844856074095 | K111076 | 000 |
00844856074088 | K111076 | 000 |
00844856068872 | K111076 | 000 |
00844856068865 | K111076 | 000 |
00844856068742 | K111076 | 000 |