FDA device listing
74016464 RIMMED SPEED PIN 3.2MM X 30MM,74016467 3.2MM X 75MM NON RIMMED TROCAR SPEED PIN,ETRAMEDULLARY ALIGNMENT ROD…
FDA device listing 1058695537 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 74016464 RIMMED SPEED PIN 3.2MM X 30MM,74016467 3.2MM X 75MM NON RIMMED TROCAR SPEED PIN,ETRAMEDULLARY ALIGNMENT ROD (114861),NON RIMMED SPEED PIN 110MM STERILE (81116660, 74013401),NON RIMMED SPEED PIN 65MM STERILE (81116664, 74013480),NON RIMMED SPEED PIN 80MM STERILE (81116665, 74013490),RIMMED SPEED PIN 30MM STERILE (81116661, 74013470),RIMMED SPEED PIN 45MM STERILE (81116662, 74013471),RIMMED… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HSX, KRR, NPJ |
| Device names | HSX - Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, KRR - Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, NPJ - Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3520, 888.3540, 888.3560 |
| 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