Otis Biotech Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 3
What Otis Biotech Co., Ltd. makes
Otis Biotech Co., Ltd. manufactures orthopedic fixation hardware, including the ULC Spinal Pedicle Screw System for spinal stabilization, and modular total joint replacements such as the Prolixus Total Knee System and Multifit Total Hip System.
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.
Catalogue
Ulc Spinal Pedicle Screw System Ref K083077
Regimes: 510(k) Registry: 510(k)Prolixus Total Knee System Ref K170534
Regimes: 510(k) Registry: 510(k)Multifit Total Hip System Ref K101472
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Otis Biotech Co., Ltd. have in the registry?
The registry currently lists 3 devices for Otis Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Otis Biotech Co., Ltd.'s devices?
Among its 3 most recently registered devices, Otis Biotech Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Otis Biotech Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Otis Biotech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Otis Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Otis Biotech Co., Ltd. include ULC SPINAL PEDICLE SCREW SYSTEM, PROLIXUS TOTAL KNEE SYSTEM and MULTIFIT TOTAL HIP SYSTEM.