FDA device listing
0.045 SMOOTH OLIVE WIRE, ARSENAL 330-60-007,0.045 THREADED OLIVE WIRE, ARSENAL 330-60-008,0.045" X 4" K-WIRE, K-WIRE…
FDA device listing 1147876363 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 0.045 SMOOTH OLIVE WIRE, ARSENAL 330-60-007,0.045 THREADED OLIVE WIRE, ARSENAL 330-60-008,0.045" X 4" K-WIRE, K-WIRE INSTRUMENT 330-60-010,0.062" X 4" K-WIRE, ARSENAL 330-60-009,11 IN REAMER/IM ROD (K0001101E),1450195 Gripper,1456-7005 - 1456-7010 Distractor - 5 to 10,182-1-21235 Clavical Nail Thread 4.25 x 50LT,182-1-21238 Clavical Nail Thread 5.25 x 50LT,182-1-21241 Clavical Nail Thread 6.25 x… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| 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