FDA device listing
Interseal Alt Shell Impactor Group 1 (81000000),Interseal Alt Shell Impactor Group 3 (83000000),Odyssey DCF FEM RESECT…
FDA device listing 1001338018 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Interseal Alt Shell Impactor Group 1 (81000000),Interseal Alt Shell Impactor Group 3 (83000000),Odyssey DCF FEM RESECT BLOCK W/WIDE ANT SLOT SZ 1,Odyssey DCF FEM RESECT BLOCK W/WIDE ANT SLOT SZ 2,Odyssey DCF FEM RESECT BLOCK W/WIDE ANT SLOT SZ 4,PROFEMUR® CEMENTED STEM INSERT FOR CEMENTED STEMS (PRCMSTIN),Profemur Modular Neck,TISSUE PROTECTOR SALVATION™ MIDFOOT NAIL (SMN10012),TRANSCEND® MODULAR… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | MDM |
| Device names | MDM - Instrument, Manual, Surgical, General Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| 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