FDA device listing
Mako Shoulder Application
FDA device listing 1306644220 · STRYKER CORP.
Key facts
| Proprietary names | Mako Shoulder Application |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K242373 |
| Product codes | OLO |
| Device names | OLO - Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560 |
| Review panels | Neurology |
| Registered establishments | MAKO SURGICAL CORP., STRYKER EMEA Supply Chain Services, STRYKER IRELAND LTD., INSTRUMENTS DIVISION, STRYKER LEIBINGER GMBH & CO. KG |
| Establishment registrations | 8010177, 9616696, 3008837339, 3017410889 |
| FEI numbers | 3002821504, 3003164255, 3005985723, 3008837339 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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