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 |