FDA device listing
Depth Gauge,DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme,FLEXIBLE DEPTH GUAGE,Gauge…
FDA device listing 1154504975 · STRYKER CORP.
Key facts
| Proprietary names | Depth Gauge,DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme,FLEXIBLE DEPTH GUAGE,Gauge, Depth,General Instruments,Meniscal Transplant Set,OMNIFLEX,OSTEONICS,Pangea Platform,Variable Angle Fixation |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | HTJ |
| Device names | HTJ - Gauge, Depth |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4300 |
| Review panels | Orthopedic |
| Registered establishments | MAKO SURGICAL CORP., SERF, STRYKER ENDOSCOPY, STRYKER GmbH, STRYKER LEIBINGER GMBH & CO. KG, STRYKER TRAUMA GMBH, TORNIER Inc., TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2936485, 8010177, 8031020, 9610622, 3000931034, 3004983210, 3008668801, 3010667733, 3017410889 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002807231, 3002807830, 3002821504, 3004983210, 3005985723, 3008668801, 3010667733 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| 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