The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Modulus Xlif Interbody System.
Device ID | K201692 |
510k Number | K201692 |
Device Name: | NuVasive Modulus XLIF Interbody System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Contact | Jessica Leblanc |
Correspondent | Jessica Leblanc NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Product Code | MAX |
Subsequent Product Code | OVD |
Subsequent Product Code | PHM |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-22 |
Decision Date | 2020-10-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00195377039309 | K201692 | 000 |