Bio-Lok Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bio-Lok Intl., Inc. makes
Bio-Lok Intl., Inc. produces orthopedic implants with surface modifications, including the Silhouette™ IC and Silhouette™ implants with optional Laser-Lok™ surface treatment for enhanced fixation, as well as the BoneGen™ TR implant designed for bone regeneration applications.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Bonegen - Tr Ref K060285
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Lok Intl., Inc. have in the registry?
The registry currently lists 3 devices for Bio-Lok Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Lok Intl., Inc.'s devices?
Among its 3 most recently registered devices, Bio-Lok Intl., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bio-Lok Intl., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bio-Lok Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Lok Intl., Inc. in the registry?
The most recently registered devices listed for Bio-Lok Intl., Inc. include MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS, SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) and BONEGEN - TR.