The following data is part of a premarket notification filed by Neurostructures, Llc with the FDA for Resolute Facet Screw System.
Device ID | K121551 |
510k Number | K121551 |
Device Name: | RESOLUTE FACET SCREW SYSTEM |
Classification | System, Facet Screw Spinal Device |
Applicant | NEUROSTRUCTURES, LLC 4628 NORTHPARK DR Colorado Springs, CO 80918 |
Contact | Meredith May |
Correspondent | Meredith May NEUROSTRUCTURES, LLC 4628 NORTHPARK DR Colorado Springs, CO 80918 |
Product Code | MRW |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-25 |
Decision Date | 2012-10-23 |
Summary: | summary |