The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Lateral Plate System.
| Device ID | K091071 |
| 510k Number | K091071 |
| Device Name: | NUVASIVE LATERAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Han Fan |
| Correspondent | Han Fan NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517054869 | K091071 | 000 |
| 00887517052520 | K091071 | 000 |
| 00887517052537 | K091071 | 000 |
| 00887517052544 | K091071 | 000 |
| 00887517052551 | K091071 | 000 |
| 00887517052568 | K091071 | 000 |
| 00887517052582 | K091071 | 000 |
| 00887517052599 | K091071 | 000 |
| 00887517053008 | K091071 | 000 |
| 00887517053015 | K091071 | 000 |
| 00887517053022 | K091071 | 000 |
| 00887517053039 | K091071 | 000 |
| 00887517054814 | K091071 | 000 |
| 00887517054821 | K091071 | 000 |
| 00887517054838 | K091071 | 000 |
| 00887517054845 | K091071 | 000 |
| 00887517054852 | K091071 | 000 |
| 00887517052513 | K091071 | 000 |