FDA device listing
Angled Awl,Curved Awl,Guided Awl,Guided Straight Awl,Lumbar Punch Awl,Punch Awl,STALIF C Ball-Joint Awl,STALIF C U-Joint…
FDA device listing 1306717517 · Alva Prototypes Inc
Key facts
| Proprietary names | Angled Awl,Curved Awl,Guided Awl,Guided Straight Awl,Lumbar Punch Awl,Punch Awl,STALIF C Ball-Joint Awl,STALIF C U-Joint Awl,T-Handle Awl, Extended |
|---|---|
| Owner/operator | Alva Prototypes Inc |
| Owner/operator number | 10055714 |
| Product codes | HWJ |
| Device names | HWJ - Awl |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | ALVA PROTOTYPES INC |
| Establishment registrations | 3012234585 |
| FEI numbers | 3012234585 |
| Establishment operations | Contract Manufacturer, Remanufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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