Isotis NV
Country not established
- Devices
- 8
What Isotis NV makes
Isotis NV manufactures bone void fillers, including demineralized bone matrix (DBM) putties and pastes for orthopedic and dental applications, as well as syringes and plugging devices for surgical use. Their products include OSSATURA BCP for bone void filling, ACCELL CONNEXUS and ORTHOBLAST II DBM formulations, and OSSATURA DENTAL for dental bone regeneration. Additional items include the OPEN BORE SYRINGE, SHUTTLE STOP, and SYNPLUG for procedural use, alongside ACCELI DBM in various syringe sizes.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices. Their products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Ossatura Bcp Bone Void Filler Ref K030131
Regimes: 510(k) Registry: 510(k)Accell Connexus Demineralized Bone Matrix Putty Ref K060306
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ossatura Dental Ref K031813
Regimes: 510(k) Registry: 510(k)Open Bore Syringe Ref K041344
Regimes: 510(k) Registry: 510(k)Shuttle Stop Ref K000587
Regimes: 510(k) Registry: 510(k)Synplug Ref K010840
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isotis NV have in the registry?
The registry currently lists 8 devices for Isotis NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isotis NV's devices?
Among its 8 most recently registered devices, Isotis NV has devices listed in FDA 510(k) (8 devices).
What risk classes do Isotis NV's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Isotis NV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isotis NV in the registry?
The most recently registered devices listed for Isotis NV include OSSATURA BCP BONE VOID FILLER, ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY, ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY and OSSATURA DENTAL.