Omnlife Science
Country not established
- Devices
- 6
What Omnlife Science makes
Omnlife Science manufactures modular orthopedic implants for hip and knee replacements, including acetabular cups, femoral heads, and tibial components. Their products include the APEX Modular Head in multiple sizes, the APEX Hip System with bipolar heads, and the APEX Knee System with modular tibia components. The company also offers modifications to existing knee systems and modular acetabular cups designed for customizable joint reconstruction.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States, where its products are registered for orthopedic use.
Catalogue
Apex Modular Head, Size 28, 32, 26 And 40 MM+10.5 Offset, Models 302810, 303210, 303610, 304010 Ref K101575
Regimes: 510(k) Registry: 510(k)OMNI Interface Acetabular System Ref K142201
Regimes: 510(k) Registry: 510(k)Modification To: Apex Knee System Ref K073602
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Apex Knee Modular Tibia System Ref K101994
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omnlife Science have in the registry?
The registry currently lists 6 devices for Omnlife Science. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnlife Science's devices?
Among its 6 most recently registered devices, Omnlife Science has devices listed in FDA 510(k) (6 devices).
What risk classes do Omnlife Science's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Omnlife Science's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omnlife Science in the registry?
The most recently registered devices listed for Omnlife Science include APEX MODULAR HEAD, SIZE 28, 32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210, 303610, 304010, OMNI Interface Acetabular System, MODIFICATION TO: APEX KNEE SYSTEM and APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM).