FDA device listing
47563 – Fluted Surgical Drill Bit, Single Use, non-sterile,7601-N90009-K Navigated Short ø2.3 mm Drill Bit,7601-N90010-K…
FDA device listing 1070659114 · Unique Instruments Inc.
Key facts
| Proprietary names | 47563 – Fluted Surgical Drill Bit, Single Use, non-sterile,7601-N90009-K Navigated Short ø2.3 mm Drill Bit,7601-N90010-K Navigated Short ø2.8 mm Drill Bit,ACL Workstation,AR-9202-01H UNIVERS II Reamer with Hudson Connect,AR-9202-02H USP II Reamer 6 Hudson,AVIATOR,AVIATOR DRILL BIT,AVS ANCHOR-C CERVICAL CAGE SYSTEM,AVS ANCHOR-L LUMBAR CAGE SYSTEM,Cannulated Countersink 8mm,Cannulated Drill… |
|---|---|
| Owner/operator | Unique Instruments Inc. |
| Owner/operator number | 10042005 |
| 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 | ORCHID UNIQUE |
| Establishment registrations | 1828288 |
| FEI numbers | 1828288 |
| 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