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 |