FDA device listing
Holesaw 14mm Dia 5mm Drive 66523014,Holesaw 14mm Dia Tall 5mm Drive 66523214,Holesaw 16mm Dia 5mm Drive 66523016,Holesaw…
FDA device listing 1811854025 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Holesaw 14mm Dia 5mm Drive 66523014,Holesaw 14mm Dia Tall 5mm Drive 66523214,Holesaw 16mm Dia 5mm Drive 66523016,Holesaw 16mm Dia Tall 5mm Drive 66523216,Holesaw 18mm Dia 5mm Drive 66523018 |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HSO |
| Device names | HSO - Saw |
| 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