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510(k) Data Aggregation
K Number
K143039Device Name
CrossRoads Screw System
Manufacturer
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
Date Cleared
2015-01-16
(86 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CrossRoads Screw System is indicated for fracture repair and fixation, reconstruction and arthrodesis of bones appropriate for the size of the device.
Device Description
The CrossRoads Screw System is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy.
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K Number
K141857Device Name
CrossTie Intraosseous Fixation System
Manufacturer
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
Date Cleared
2015-01-08
(182 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
Device Description
The CrossTie™ Intraosseous Fixation System is manufactured from implant grade PEEK. The implant is a one-piece construct designed to be press-fit into the intraosseous space of two adjoining bones to aid in fusion. The proximal and distal ends of the implant have barb-type features for securing the implant in position. The implant also features a hole in the distal end of the implant to be used at the surgeon's discretion to assist in joint reduction.
The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.
The design features of the CrossTie™ Intraosseous Fixation System are summarized below:
- Implant Grade PEEK o
- Sized to accommodate patient anatomy O
- O Solid, one piece construction for all devices
- Proximal and distal barb-like features for secure placement o
- Hole to optionally aid in joint reduction O
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