The following data is part of a premarket notification filed by Neurovention Llc with the FDA for Neuro Vention Laminplasty Plating System.
Device ID | K121276 |
510k Number | K121276 |
Device Name: | NEURO VENTION LAMINPLASTY PLATING SYSTEM |
Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
Applicant | NEUROVENTION LLC 4628 NORTHPARK DRIVE Meredith May, CO 80918 |
Contact | Meredith May |
Correspondent | Meredith May NEUROVENTION LLC 4628 NORTHPARK DRIVE Meredith May, CO 80918 |
Product Code | NQW |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-27 |
Decision Date | 2012-08-29 |
Summary: | summary |