FDA device listing
MICRO SCAPHOID VERSALOCK PLATE 1.5mm - LARGE,MICRO SCAPHOID VERSALOCK PLATE 1.5mm - SMALL,VERSALOCK CONTOURED VOLAR…
FDA device listing 1723526138 · Ortho Max Inc
Key facts
| Proprietary names | MICRO SCAPHOID VERSALOCK PLATE 1.5mm - LARGE,MICRO SCAPHOID VERSALOCK PLATE 1.5mm - SMALL,VERSALOCK CONTOURED VOLAR LOCKING PLATE - LEFT 22,0 x 34,0mm,VERSALOCK CONTOURED VOLAR LOCKING PLATE - LEFT 22,0 x 42,0mm,VERSALOCK CONTOURED VOLAR LOCKING PLATE - LEFT 26,0 x 34,0mm,VERSALOCK CONTOURED VOLAR LOCKING PLATE - LEFT 26,0 x 41,0mm,VERSALOCK CONTOURED VOLAR LOCKING PLATE - RIGHT 22,0 x… |
|---|---|
| Owner/operator | Ortho Max Inc |
| Owner/operator number | 10095220 |
| Premarket submissions | K260390 |
| Product codes | HRS, HWC |
| Device names | HRS - Plate, Fixation, Bone, HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | ORTHO MAX INC |
| Establishment registrations | 3013843230 |
| FEI numbers | 3013843230 |
| Establishment operations | Complaint File Establishment |
| 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