FDA device listing
90 DEG OSTEOTOME 10X10MM,CUP CURETTE LEFT 5.0MM,CUP CURETTE RIGHT 5.0MM,CURVED OSTEOTOME 6MM,CURVED OSTOTOME…
FDA device listing 2066050484 · THE CRETEX COMPANIES, INC.
Key facts
| Proprietary names | 90 DEG OSTEOTOME 10X10MM,CUP CURETTE LEFT 5.0MM,CUP CURETTE RIGHT 5.0MM,CURVED OSTEOTOME 6MM,CURVED OSTOTOME 12MM,Harmony Posterior,HEADLESS PIN PULLER,IMPACTOR OSTEO ASM 21MM L,IMPACTOR OSTEO ASM 24MM L,IMPACTOR OSTEO ASM 24MM R,MIS FLEX SPACER ADAPTER 3.4MM,Optio-C (Anterior Cervical System),OSTEOTOME IMPACTOR LEFT 21MM,OSTEOTOME IMPACTOR RIGHT 24MM,OXF MP 10DEG FMRL DRILL GUIDE,OXF MP 10DEG… |
|---|---|
| Owner/operator | THE CRETEX COMPANIES, INC. |
| Owner/operator number | 9001389 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | RMS CO., rms Surgical |
| Establishment registrations | 2183946, 3010009693 |
| FEI numbers | 1000116116, 3010009693 |
| 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