Search Results
Found 2 results
510(k) Data Aggregation
K Number
K162179Device Name
osteo-WEDGE II ® Open Wedge Bone Locking Plate System
Manufacturer
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA
Date Cleared
2017-01-10
(159 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The osteo-WEDGE II ® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Device Description
The osteo-WEDGE II® Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The fully threaded screws are available in 2 diameters, with numerous lengths and previously cleared under K111326.
Ask a Question
K Number
K142534Device Name
HyProCure II
Manufacturer
Graham Medical Technologies, L.L.C. dba GraMedica
Date Cleared
2014-10-03
(24 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Graham Medical Technologies, L.L.C. dba GraMedica
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
Device Description
The HyProCure II is an implant which stabilizes the talus on the tarsal mechanism. The system consists of an implant designed to be inserted into the sinus tarsi and corresponding instrumentation to facilitate insertion.
Ask a Question
Page 1 of 1