FDA device listing
Anato¿ Hip System,Anato¿ Hip System Instrumentation,Bixcut Reamers,Direct Anterior Instruments
FDA device listing 2034310131 · STRYKER CORP.
Key facts
| Proprietary names | Anato¿ Hip System,Anato¿ Hip System Instrumentation,Bixcut Reamers,Direct Anterior Instruments |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K123604 |
| Product codes | LPH, LZO, MAY, MBL, MEH |
| Device names | LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, MAY - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish, MBL - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, MEH - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3353, 888.3358 |
| Review panels | Orthopedic |
| Registered establishments | HOWMEDICA OSTEONICS CORP, STRYKER IRELAND OSTEONICS, Stryker (Suzhou) Medical Technology Co.,Ltd. |
| Establishment registrations | 2249697, 9616680, 3007913880 |
| FEI numbers | 3002459190, 3003070421, 3007913880 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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