The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Long Lateral Spinal System.
| Device ID | K122081 |
| 510k Number | K122081 |
| Device Name: | NUVASIVE LONG LATERAL SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Elias Ketchum |
| Correspondent | Elias Ketchum 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 | 2012-07-16 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517184337 | K122081 | 000 |
| 00887517183514 | K122081 | 000 |
| 00887517183507 | K122081 | 000 |
| 00887517182999 | K122081 | 000 |
| 00887517182982 | K122081 | 000 |
| 00887517182975 | K122081 | 000 |
| 00887517182937 | K122081 | 000 |
| 00887517182920 | K122081 | 000 |
| 00887517182913 | K122081 | 000 |
| 00887517182906 | K122081 | 000 |
| 00887517182593 | K122081 | 000 |
| 00887517182586 | K122081 | 000 |
| 00887517182579 | K122081 | 000 |
| 00887517113481 | K122081 | 000 |
| 00887517183521 | K122081 | 000 |
| 00887517183538 | K122081 | 000 |
| 00887517184320 | K122081 | 000 |
| 00887517184313 | K122081 | 000 |
| 00887517184306 | K122081 | 000 |
| 00887517183996 | K122081 | 000 |
| 00887517183989 | K122081 | 000 |
| 00887517183972 | K122081 | 000 |
| 00887517183934 | K122081 | 000 |
| 00887517183927 | K122081 | 000 |
| 00887517183910 | K122081 | 000 |
| 00887517183903 | K122081 | 000 |
| 00887517183590 | K122081 | 000 |
| 00887517183583 | K122081 | 000 |
| 00887517183576 | K122081 | 000 |
| 00887517113467 | K122081 | 000 |