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 |