FDA device listing
AEQUALIS,AEQUALIS FRACTURE,Aequalis Fx2,Aequalis Instrument,Aequalis PerFORM,AEQUALIS RESURFACING HEAD,Angeld Farabeuf…
FDA device listing 1459340439 · STRYKER CORP.
Key facts
| Proprietary names | AEQUALIS,AEQUALIS FRACTURE,Aequalis Fx2,Aequalis Instrument,Aequalis PerFORM,AEQUALIS RESURFACING HEAD,Angeld Farabeuf clamp,CLAMP,Farabeuf clamp,Flex Shoulder System,FOREFOOT SET,General Instruments,HLS KNEETEC,HLS UNI EVOLUTION,Jaw Clamp, Curved Offs. Counterclockwise,Jaw Clamp Large Offset Curved,Jaw Clamp Large offset Straight,Jaw Clamp offset Overbite,Jaw Clamp offset Underbite,Jaw Clamp… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | HXD |
| Device names | HXD - Clamp |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HOWMEDICA OSTEONICS CORP, STRYKER Communications, Inc., STRYKER ENDOSCOPY, STRYKER GmbH, STRYKER LEIBINGER GMBH & CO. KG, Stryker (Suzhou) Medical Technology Co.,Ltd., TORNIER Inc., TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2031963, 2249697, 2936485, 8010177, 8031020, 3000931034, 3004983210, 3007913880, 3010667733 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002807830, 3002821504, 3002975342, 3003070421, 3004983210, 3007913880, 3010667733 |
| 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