The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive Next Generation Nvm5 System.
Device ID | K162313 |
510k Number | K162313 |
Device Name: | NuVasive Next Generation NVM5 System |
Classification | Neurosurgical Nerve Locator |
Applicant | NUVASIVE INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
Contact | Mary Adams |
Correspondent | Mary Adams NUVASIVE INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
Product Code | PDQ |
Subsequent Product Code | ETN |
Subsequent Product Code | GWF |
Subsequent Product Code | HAW |
Subsequent Product Code | IKN |
Subsequent Product Code | OLO |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-18 |
Decision Date | 2017-03-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887517163271 | K162313 | 000 |
00887517824530 | K162313 | 000 |
00887517824523 | K162313 | 000 |
00887517824516 | K162313 | 000 |
00887517824448 | K162313 | 000 |
00887517824431 | K162313 | 000 |
00887517824424 | K162313 | 000 |
00887517824417 | K162313 | 000 |
00887517824400 | K162313 | 000 |
00887517818997 | K162313 | 000 |
00195377097439 | K162313 | 000 |
00195377097422 | K162313 | 000 |
00195377097415 | K162313 | 000 |
00887517824554 | K162313 | 000 |
00887517824578 | K162313 | 000 |
00887517060358 | K162313 | 000 |
00887517973405 | K162313 | 000 |
00887517960344 | K162313 | 000 |
00887517960337 | K162313 | 000 |
00887517960320 | K162313 | 000 |
00887517957368 | K162313 | 000 |
00887517939876 | K162313 | 000 |
00887517939869 | K162313 | 000 |
00887517939852 | K162313 | 000 |
00887517939845 | K162313 | 000 |
00887517939838 | K162313 | 000 |
00887517939821 | K162313 | 000 |
00195377083272 | K162313 | 000 |