Neucoll, Inc.
Country not established
- Devices
- 2
What Neucoll, Inc. makes
Neucoll, Inc. manufactures bone graft matrices, including COLLAGRAFT STRIP BONE GRAFT MATRIX (available in single, triple, or sextuple strip configurations) and COLLAGRAFT™ BONE GRAFT MATRIX, designed for use as bone fillers in surgical procedures.
These products are regulated under FDA pathways, with some classified as Class II and others as Class III, requiring 510(k) clearance or PMA approval. The company is based in the United States.
Catalogue
Collagraft Strip Bone Graft Matrix (For Use As A Bone Filler), Model 1X, 3X, 6X (1, 3 Or 6 Strips Per Box) Ref K000122
Regimes: 510(k) Registry: 510(k)Collagraft(Tm) Bone Graft Matrix Ref P900039
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Neucoll, Inc. have in the registry?
The registry currently lists 2 devices for Neucoll, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neucoll, Inc.'s devices?
Among its 2 most recently registered devices, Neucoll, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Neucoll, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Neucoll, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Neucoll, Inc. in the registry?
The most recently registered devices listed for Neucoll, Inc. include COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X, 3X, 6X (1, 3 OR 6 STRIPS PER BOX) and COLLAGRAFT(TM) BONE GRAFT MATRIX.