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Found 5 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.
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K Number
K142478Device Name
opti-Toe
Manufacturer
Graham Medical Technologies, L.L.C. (d.b.a.GraMedica)
Date Cleared
2015-05-29
(268 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Graham Medical Technologies, L.L.C. (d
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.
Device Description
The GraMedica opti-Toe is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. The implants are offered in two sizes, small and large, and the middle phalangeal component is offered with and without a 10 degree angulation.
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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.
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K Number
K111326Device Name
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
Manufacturer
GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
Date Cleared
2011-07-06
(56 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoWedge™ Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction 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 OsteoWedge™ 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 plates are available in six (6) wedge sizes. The fully threaded screws are available in 2 diameters, with numerous lengths.
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K Number
K042030Device Name
HYPROCURE SUBTALAR IMPLANT SYSTEM
Manufacturer
GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
Date Cleared
2004-09-16
(50 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Device Description
Not Found
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