The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Archon Anterior Cervical Plate Syste,.
Device ID | K122910 |
510k Number | K122910 |
Device Name: | ARCHON ANTERIOR CERVICAL PLATE SYSTE, |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
Contact | Cynthia Adams |
Correspondent | Cynthia Adams NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-21 |
Decision Date | 2012-10-11 |
Summary: | summary |