The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Laminoplasty Fixation System.
| Device ID | K091623 |
| 510k Number | K091623 |
| Device Name: | LAMINOPLASTY FIXATION SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| 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 | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517074423 | K091623 | 000 |
| 00887517071927 | K091623 | 000 |
| 00887517071910 | K091623 | 000 |
| 00887517071903 | K091623 | 000 |
| 00887517071392 | K091623 | 000 |
| 00887517071385 | K091623 | 000 |
| 00887517071378 | K091623 | 000 |
| 00887517071361 | K091623 | 000 |
| 00887517071354 | K091623 | 000 |
| 00887517071347 | K091623 | 000 |
| 00887517071330 | K091623 | 000 |
| 00887517071323 | K091623 | 000 |
| 00887517071316 | K091623 | 000 |
| 00887517071309 | K091623 | 000 |
| 00887517071934 | K091623 | 000 |
| 00887517071941 | K091623 | 000 |
| 00887517072474 | K091623 | 000 |
| 00887517072467 | K091623 | 000 |
| 00887517072450 | K091623 | 000 |
| 00887517072443 | K091623 | 000 |
| 00887517072436 | K091623 | 000 |
| 00887517072429 | K091623 | 000 |
| 00887517072412 | K091623 | 000 |
| 00887517072405 | K091623 | 000 |
| 00887517071996 | K091623 | 000 |
| 00887517071989 | K091623 | 000 |
| 00887517071972 | K091623 | 000 |
| 00887517071965 | K091623 | 000 |
| 00887517071958 | K091623 | 000 |
| 00887517070890 | K091623 | 000 |