FDA device listing
1456-7700 Screw Guide,1.4MM Guide Wire (CSS-040-14),(156172) Locking Drill Guide 2.0mm,(156173) Locking Drill Guide…
FDA device listing 1771032197 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 1456-7700 Screw Guide,1.4MM Guide Wire (CSS-040-14),(156172) Locking Drill Guide 2.0mm,(156173) Locking Drill Guide 2.8mm,3 x 75 mm Guide Pin (9722908),4.0mm RSP BASEPLATE DRILL & LOCKING SCREW GUIDE (804-03-048),604-14-006 CUT GUIDE SIZE 6 ALTURA,604-15-004 TALAR RECUT GUIDE SIZE 5 ALTURA,604-30-006 Stem Prep Guide - Size 6,604-42-001 Starter Punch Guide,604-61-005 Talar Trial, Size 5,804-06-221… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | FZX |
| Device names | FZX - Guide, Surgical, Instrument |
| 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