FDA device listing
Orthosis, Spinal Pedicle Fixation
FDA device listing 1701289079 · STRYKER CORP.
Key facts
| Owner/operator | STRYKER CORP. |
|---|---|
| Owner/operator number | 1811755 |
| Premarket submissions | K192818 |
| Product codes | MNI, NDN, NKB, PML |
| Device names | MNI - Orthosis, Spinal Pedicle Fixation, NDN - Cement, Bone, Vertebroplasty, NKB - Thoracolumbosacral Pedicle Screw System, PML - Bone Cement, Posterior Screw Augmentation |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3027, 888.3070 |
| Review panels | Orthopedic |
| Registered establishments | HOWMEDICA INTERNATIONAL S. DE R.L.,, Stryker Instruments, Stryker Ireland Ltd. Instruments Division, Innovation Centre, STRYKER PUERTO RICO, LLC. |
| Establishment registrations | 2648666, 9610726, 3015967359, 3040335671 |
| FEI numbers | 2648666, 3002807172, 3015967359, 3040335671 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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