The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Pulse System.
| Device ID | K180038 |
| 510k Number | K180038 |
| Device Name: | NuVasive Pulse System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | OLO |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GWF |
| Subsequent Product Code | HAW |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JAA |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | OWB |
| Subsequent Product Code | PDQ |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-05 |
| Decision Date | 2018-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517984814 | K180038 | 000 |
| 00887517986528 | K180038 | 000 |
| 00887517939807 | K180038 | 000 |
| 00887517011541 | K180038 | 000 |
| 00887517011534 | K180038 | 000 |
| 00887517001627 | K180038 | 000 |
| 00887517990785 | K180038 | 000 |
| 00887517990778 | K180038 | 000 |
| 00887517990761 | K180038 | 000 |
| 00887517990754 | K180038 | 000 |
| 00887517955319 | K180038 | 000 |
| 00887517945822 | K180038 | 000 |
| 00887517945815 | K180038 | 000 |
| 00887517931771 | K180038 | 000 |
| 00887517834157 | K180038 | 000 |
| 00887517994141 | K180038 | 000 |
| 00887517994134 | K180038 | 000 |
| 00887517994127 | K180038 | 000 |
| 00887517990792 | K180038 | 000 |
| 00887517990808 | K180038 | 000 |
| 00887517975065 | K180038 | 000 |
| 00887517973900 | K180038 | 000 |
| 00887517973887 | K180038 | 000 |
| 00887517973870 | K180038 | 000 |
| 00887517973863 | K180038 | 000 |
| 00887517973801 | K180038 | 000 |
| 00887517973160 | K180038 | 000 |
| 00887517972309 | K180038 | 000 |
| 00887517953469 | K180038 | 000 |
| 00887517988065 | K180038 | 000 |
| 00887517988058 | K180038 | 000 |
| 00887517988041 | K180038 | 000 |
| 00887517975812 | K180038 | 000 |
| 00887517973894 | K180038 | 000 |
| 00887517814128 | K180038 | 000 |
| 00887517996138 | K180038 | 000 |
| 00887517996121 | K180038 | 000 |
| 00887517991911 | K180038 | 000 |