The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Stimulation/dissection Instruments.
Device ID | K112709 |
510k Number | K112709 |
Device Name: | STIMULATION/DISSECTION INSTRUMENTS |
Classification | Stimulator, Nerve |
Applicant | NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
Contact | Elias Ketchum |
Correspondent | Elias Ketchum NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-19 |
Decision Date | 2012-02-09 |
Summary: | summary |