FDA device listing
F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 10mm 12° 02P02904,F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 11mm 12°…
FDA device listing 1981830866 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 10mm 12° 02P02904,F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 11mm 12° 02P02905,F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 12mm 12° 02P02906,F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 13mm 12° 02P02907,F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 14mm 12° 02P02908,F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 15mm 12° 02P02909,F3D Straight 3PD… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | MAX, ODP |
| Device names | MAX - Intervertebral Fusion Device With Bone Graft, Lumbar, ODP - Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3080 |
| Review panels | Orthopedic |
| Registered establishments | STRAITS ORTHOPAEDICS (MFG) SDN BHD |
| Establishment registrations | 3025603301, 3033509898, 3036756245 |
| FEI numbers | 3025603301, 3033509898, 3036756245 |
| Establishment operations | Contract Manufacturer |
| 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