The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Spherx Ii System.
| Device ID | K091502 |
| 510k Number | K091502 |
| Device Name: | NUVASIVE SPHERX II SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-21 |
| Decision Date | 2009-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517265678 | K091502 | 000 |
| 00887517036056 | K091502 | 000 |
| 00887517050069 | K091502 | 000 |
| 00887517050076 | K091502 | 000 |
| 00887517051851 | K091502 | 000 |
| 00887517068637 | K091502 | 000 |
| 00887517068644 | K091502 | 000 |
| 00887517068651 | K091502 | 000 |
| 00887517103680 | K091502 | 000 |
| 00887517103697 | K091502 | 000 |
| 00887517104113 | K091502 | 000 |
| 00887517104144 | K091502 | 000 |
| 00887517125835 | K091502 | 000 |
| 00887517125842 | K091502 | 000 |
| 00887517125859 | K091502 | 000 |
| 00887517258243 | K091502 | 000 |
| 00887517265647 | K091502 | 000 |
| 00887517199843 | K091502 | 000 |