The following data is part of a premarket notification filed by Alphatec/nexmed with the FDA for Zodiac Spinal Fixation System.
Device ID | K051286 |
510k Number | K051286 |
Device Name: | ZODIAC SPINAL FIXATION SYSTEM |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
Contact | Ellen A Yarnall |
Correspondent | Ellen A Yarnall ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
Product Code | MNH |
Subsequent Product Code | KWP |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-18 |
Decision Date | 2005-06-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844856069022 | K051286 | 000 |
00844856069015 | K051286 | 000 |
00844856069008 | K051286 | 000 |
00844856068995 | K051286 | 000 |
00844856068988 | K051286 | 000 |
00844856068971 | K051286 | 000 |
00844856068964 | K051286 | 000 |
00844856057500 | K051286 | 000 |
00844856057494 | K051286 | 000 |