Search Results
Found 5 results
510(k) Data Aggregation
K Number
K212334Device Name
GEO Extremity and Ankle Plating System
Manufacturer
Gramercy Extremity Orthopedics, LLC
Date Cleared
2021-09-21
(56 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Gramercy Extremity Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K210534Device Name
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Manufacturer
Gramercy Extremity Orthopedics, LLC
Date Cleared
2021-03-26
(30 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Gramercy Extremity Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.
Device Description
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.
Ask a Question
K Number
K202817Device Name
GEO Bone Screw System
Manufacturer
Gramercy Extremity Orthopedics, LLC
Date Cleared
2020-10-22
(28 days)
Product Code
HWC, HTN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Gramercy Extremity Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.
Device Description
The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.
Ask a Question
K Number
K200108Device Name
GEO 1st MTP Joint Arthrodesis Plating System
Manufacturer
Gramercy Extremity Orthopedics, LLC
Date Cleared
2020-03-26
(69 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Gramercy Extremity Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GEO 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion or revision surgery.
Device Description
The GEO 188 MTP Joint Arthrodesis Plating System consists of anatomically contoured, low- profile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. All screws are offered in lengths of 10-40mm. The system also includes associated instrumentation consisting of plate tacks, quide-wire, drill bit, drill bit, drill guides (locking and non-locking), AO driver tip, reamers, depth gauge, non-locking drill guide handle, AO driver handle, and templates for plate and reamer sizing. All GEO 1ª MTP Joint Arthrodesis Plating System components (implants and instruments) are provided sterile and for single use only.
Ask a Question
K Number
K182212Device Name
Geo Staple System
Manufacturer
Gramercy Extremity Orthopedics, LLC
Date Cleared
2019-01-11
(149 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Gramercy Extremity Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.
Device Description
The GEO Stable System consists of symmetric, barbed and smooth, superelastic Nitinol allov compression bone staples in varying lengths and widths. The System also includes associated instrumentation consisting of a stable inserter, drill bit and locator pins. The nitinol implant material conforms to ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. GEO Staples are offered in widths ranging from 8mm – 25mm. To facilitate implantation, GEO Staples are provided preloaded in the Staple Inserter. All GEO Staple System components (implants and instruments) are provided sterile and for single use only.
Ask a Question
Page 1 of 1