FDA device listing
Aequalis Flex Revive,Aequalis Perform+,CalcLock,Compression Staple System,Hoffmann LRF,IMN™ Instruments drill,Latitude…
FDA device listing 1035153527 · STRYKER CORP.
Key facts
| Proprietary names | Aequalis Flex Revive,Aequalis Perform+,CalcLock,Compression Staple System,Hoffmann LRF,IMN™ Instruments drill,Latitude EV,Made-To-Order,MaxLock,MaxTorque,NexFix,Pangea Platform,Pangea Torque Limiting Adapter,Tornier Extraction,Tornier Humeral Nail,Tornier Perform Humeral System,Tornier Perform Reversed,Tornier Simpliciti Shoulder System |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | HWE |
| Device names | HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SERF, STRYKER GmbH, Stryker Instruments, STRYKER IRELAND LTD., INSTRUMENTS DIVISION, Stryker Ireland Ltd. Instruments Division, Innovation Centre, STRYKER MANUFACTURING KALAMAZOO, STRYKER PUERTO RICO, LLC., Stryker (Suzhou) Medical Technology Co.,Ltd., STRYKER TRAUMA GMBH, Stryker US Supply Chain Operations, TORNIER Inc., TORNIER, INC. and 2 more |
| Establishment registrations | 1043534, 1649390, 2648666, 8031020, 9610622, 9616696, 3000931034, 3004983210, 3007913880, 3007997036, 3008668801, 3010667733, 3012497308, 3015967359, 3040335671 |
| FEI numbers | 1043534, 2648666, 3000718467, 3000931034, 3002807231, 3002807830, 3003164255, 3004983210, 3007913880, 3007997036, 3008668801, 3010667733, 3012497308, 3015967359, 3040335671 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 10–99 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