The following data is part of a premarket notification filed by N Spine, Inc. with the FDA for Ngarde System.
| Device ID | K072685 |
| 510k Number | K072685 |
| Device Name: | NGARDE SYSTEM |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | N SPINE, INC. 6244 FERRIS SQUARE, SUITE B San Diego, CA 92121 -3239 |
| Contact | Jude V Paganelli |
| Correspondent | Jude V Paganelli N SPINE, INC. 6244 FERRIS SQUARE, SUITE B San Diego, CA 92121 -3239 |
| Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-21 |
| Decision Date | 2007-10-19 |
| Summary: | summary |