FDA device listing
MOUNTAINEER OCT, SUMMIT SI OCT, SYMPHONY OCT, SUMMIT Fixation System
FDA device listing 1337906728 · DePuy Spine, Inc.
Key facts
| Proprietary names | MOUNTAINEER OCT, SUMMIT SI OCT, SYMPHONY OCT, SUMMIT Fixation System |
|---|---|
| Owner/operator | DePuy Spine, Inc. |
| Owner/operator number | 1526439 |
| Premarket submissions | K190895 |
| Product codes | HRS, HWC, KWP, NKG |
| Device names | HRS - Plate, Fixation, Bone, HWC - Screw, Fixation, Bone, KWP - Appliance, Fixation, Spinal Interlaminal, NKG - Posterior Cervical Screw System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 888.3040, 888.3050, 888.3075 |
| Review panels | Orthopedic |
| Registered establishments | DEPUY SPINE, INC. |
| Establishment registrations | 1526439 |
| FEI numbers | 1526439 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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