The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Lessray System.
| Device ID | K173314 |
| 510k Number | K173314 |
| Device Name: | LessRay System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Manthan J. Damani |
| Correspondent | Manthan J. Damani NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-19 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517996022 | K173314 | 000 |
| 00887517994820 | K173314 | 000 |
| 00887517994813 | K173314 | 000 |
| 00887517994806 | K173314 | 000 |
| 00887517992789 | K173314 | 000 |
| 00887517976062 | K173314 | 000 |
| 00887517811936 | K173314 | 000 |
| 00887517805997 | K173314 | 000 |