FDA device listing
Diapason® Spinal System,ES2™ Augmentable Spinal System,ES2™ Spinal System,Escalate® Laminoplasty System,Mantis®…
FDA device listing 2046708289 · VB Spine, LLC
Key facts
| Proprietary names | Diapason® Spinal System,ES2™ Augmentable Spinal System,ES2™ Spinal System,Escalate® Laminoplasty System,Mantis® Redux,Mantis® Spinal System,Nile® Alternative Fixation Spinal System,Nile® Proximal Fixation Spinal System,Oasys® Occipito-Cervico-Thoracic System,Opus™ Spinal System,Radius® Spinal System,Serrato® Spinal System,Trio® & Trio+ Spinal Fixation System,XIA® 3 Spinal System,XIA® 4.5 Cortical… |
|---|---|
| Owner/operator | VB Spine, LLC |
| Owner/operator number | 10093189 |
| Premarket submissions | K222684 |
| Product codes | KWP, KWQ, NKB, NKG, NQW, OWI, PGM |
| Device names | KWP - Appliance, Fixation, Spinal Interlaminal, KWQ - Appliance, Fixation, Spinal Intervertebral Body, NKB - Thoracolumbosacral Pedicle Screw System, NKG - Posterior Cervical Screw System, NQW - Orthosis, Spine, Plate, Laminoplasty, Metal, OWI - Bone Fixation Cerclage, Sublaminar, PGM - Growing Rod System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3010, 888.3050, 888.3060, 888.3070, 888.3075 |
| Review panels | Orthopedic |
| Registered establishments | STRYKER SPINE |
| Establishment registrations | 3004024955 |
| FEI numbers | 3004024955 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database