FDA device listing
57COMPR4 Compression Pack For 4mm Mica Prostep Mica Instruments,57COMPR5 Compression Pack For 5mm Screw Prostep Mis…
FDA device listing 1167707948 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 57COMPR4 Compression Pack For 4mm Mica Prostep Mica Instruments,57COMPR5 Compression Pack For 5mm Screw Prostep Mis Lapidus System |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | KDD |
| Device names | KDD - Kit, Surgical Instrument, Disposable |
| 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