The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac 4.0 Polyaxial Spinal Fixation System.
Device ID | K071890 |
510k Number | K071890 |
Device Name: | ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
Contact | Mary Stanners |
Correspondent | Mary Stanners ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
Product Code | MNH |
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 | 2007-07-09 |
Decision Date | 2007-11-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844856024410 | K071890 | 000 |
00844856003880 | K071890 | 000 |
00844856003873 | K071890 | 000 |
00844856003866 | K071890 | 000 |
00844856003859 | K071890 | 000 |
00844856003842 | K071890 | 000 |
00844856003835 | K071890 | 000 |
00844856003828 | K071890 | 000 |
00844856002814 | K071890 | 000 |
00844856002807 | K071890 | 000 |
00844856002791 | K071890 | 000 |
00844856002784 | K071890 | 000 |
00844856002777 | K071890 | 000 |
00844856002760 | K071890 | 000 |
00844856002753 | K071890 | 000 |
00844856002746 | K071890 | 000 |
00844856002739 | K071890 | 000 |
00844856001800 | K071890 | 000 |
00844856003897 | K071890 | 000 |
00844856003903 | K071890 | 000 |
00844856024403 | K071890 | 000 |
00844856024397 | K071890 | 000 |
00844856024380 | K071890 | 000 |
00844856024373 | K071890 | 000 |
00844856024366 | K071890 | 000 |
00844856024359 | K071890 | 000 |
00844856024342 | K071890 | 000 |
00844856024335 | K071890 | 000 |
00844856023543 | K071890 | 000 |
00844856023536 | K071890 | 000 |
00844856023529 | K071890 | 000 |
00844856023512 | K071890 | 000 |
00844856023505 | K071890 | 000 |
00844856023499 | K071890 | 000 |
00844856023482 | K071890 | 000 |
00844856023475 | K071890 | 000 |
00844856023468 | K071890 | 000 |
00844856001787 | K071890 | 000 |