Neoligaments, Ltd.
Country not established
- Devices
- 7
What Neoligaments, Ltd. makes
Neoligaments, Ltd. manufactures orthopedic fixation devices, including the GRAFTOLOGER for ligament reconstruction, the FASTLOK staple and buckle fixation system for securing grafts, and the CRADLE fixation device for stabilizing tissue. Their portfolio also includes the GRAFTOLOGER PGH & ACL reconstruction instrument set and specialized reamer bits for surgical preparation.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory clearance obtained through the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their authorised status in the United States.
Catalogue
The Graftologer Ref K935753
Regimes: 510(k) Registry: 510(k)Fastlok (Staple & Buckle) Fixation System Ref K913461
Regimes: 510(k) Registry: 510(k)Cradle Fixation Device Ref K941772
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Reamer Bit Ref K930339
Regimes: 510(k) Registry: 510(k)Fastlok (Staple And Buckle) Fixation System Ref K911445
Regimes: 510(k) Registry: 510(k)Fastlok (Staple And Buckle) Fixation System Ref K904340
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Neoligaments, Ltd. have in the registry?
The registry currently lists 7 devices for Neoligaments, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neoligaments, Ltd.'s devices?
Among its 7 most recently registered devices, Neoligaments, Ltd. has devices listed in FDA 510(k) (7 devices).
What risk classes do Neoligaments, Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Neoligaments, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neoligaments, Ltd. in the registry?
The most recently registered devices listed for Neoligaments, Ltd. include THE GRAFTOLOGER, FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM, CRADLE FIXATION DEVICE and GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET.