The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Modulus Xlif Interbody System.
| Device ID | K192760 |
| 510k Number | K192760 |
| 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 | 2019-09-30 |
| Decision Date | 2019-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517018311 | K192760 | 000 |
| 00887517018304 | K192760 | 000 |
| 00887517017895 | K192760 | 000 |
| 00887517017888 | K192760 | 000 |
| 00887517017871 | K192760 | 000 |
| 00887517017864 | K192760 | 000 |