Search Results
Found 2 results
510(k) Data Aggregation
K Number
K141106Device Name
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
Manufacturer
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES
Date Cleared
2014-10-10
(164 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description
The Frontier Devices FUSIO Screw Fuze System consists of titanium bone screws of 7mm, 9.5mm, and 11mm diameter of various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw. The screws are made from titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.
Ask a Question
K Number
K100205Device Name
FRONTIER DEVICES NEURO SYSTEM
Manufacturer
FOLSOM METAL PRODUCTS, INC.
Date Cleared
2010-12-13
(322 days)
Product Code
GWO, GXR, HBW
Regulation Number
882.5320Why did this record match?
Applicant Name (Manufacturer) :
FOLSOM METAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.
Device Description
The Frontier Devices Neuro System consists of titanium bone plates and screws of various shapes and sizes. The plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Plates are 0.4 and 0.6 mm thick and come in a variety of shapes and sizes that are designed for cranial closure applications. The shapes and corresponding sizes include: Straight plates 9-12mm long (1x1, 2x2, 5 and 7 holes), Box plates 10mm x 10mm to 16mm x 16mm (4 hole), X-plate 8mm x 8mm (4 hole), Y-plate 16mm long (6 and 8 holes), Double Y-plate 18mm to 21mm long (6 and 8 hole), Strut plate 24 and 35mm long (6 and 8 hole). The burr hole covers are are made from unalloyed titanium that conforms to the ASTM F67 standard. They are 0.4 and 0.6 mm thick and are circular in shape with equi-spaced drill holes around the circumference. The burr hole covers have two basic shapes. The burr hole cover for shunt has a segment of the circular burr hole cover missing which is where a shunt device is placed. The other burr hole cover is a complete circle. The corresponding sizes include: Burr hole covers 12mm to 24mm diameter, Burr hole covers for shunt 12mm to 24mm diameter. The mesh is made from unalloyed titanium that conforms to ASTM F67 standard. They are 0.4 and 0.6mm thick and rectangular in shape, 90mm x 120mm. The screws are self-drilling screws that do not require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 1.5 to 1.8 mm in diameter and range in length from 3 to 6 mm.
Ask a Question
Page 1 of 1