FDA device listing
104.LHS-BX10 - Head Guard Box of 10,104.NPLB - Nextend Lite Bolster,104.NPL - Nextend Lite,104.NPSB - Nextend System…
FDA device listing 1070703812 · Bone Foam Inc.
Key facts
| Proprietary names | 104.LHS-BX10 - Head Guard Box of 10,104.NPLB - Nextend Lite Bolster,104.NPL - Nextend Lite,104.NPSB - Nextend System Bolster,104.NPS - Nextend System,104.NPS-SB - Nextend Scapula Bolster,104.NPS-TA - Nextend Traction Anchor,104.NPS-TB - Nextend Torso Base,104.SLPS-AB - Ax Bump,104.SLPS-HB - Hip Bolster,104.SLPS-LB - Sideline Lower Base,104.SLPS - Sideline,104.SLPS-TB - Sideline Torso… |
|---|---|
| Owner/operator | Bone Foam Inc. |
| Owner/operator number | 9046835 |
| Product codes | CCX |
| Device names | CCX - Support, Patient Position |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.6820 |
| Review panels | Anesthesiology |
| Registered establishments | BONE FOAM INC. |
| Establishment registrations | 2321033 |
| FEI numbers | 3003399881 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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