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GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

US

Last updated September 17, 2026

Information

Country
US
Address
1239 N Glenville Dr, Richardson, TX, 75081
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3012478585
DUNS Number
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Catalogue (711)

Page 15 of 15
DeviceModel / ReferenceRegistriesClassStatus
EPS Plating System Screw 11024010
FDA UDI
Class IIActive
Distal Fibula Plating System 12660007
FDA UDI
Class IIActive
EPS Plating System Screw 11024040
FDA UDI
Class IIActive
Jones/5th Metatarsal Bone Screw System 10265060
FDA UDI
Class IIActive
Jones/5th Metatarsal Bone Screw System 10264055
FDA UDI
Class IIActive
EPS Plating System 71240001
FDA UDI
Class IActive
GEO 1st MTP Joint Arthrodesis Plating System K200108
FDA 510(k)
Class IIActive
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System K210534
FDA 510(k)
Class IIActive
GEO Bone Screw System K202817
FDA 510(k)
Class IIActive
Geo Staple System K182212
FDA 510(k)
Class IIActive
GEO Extremity and Ankle Plating System K212334
FDA 510(k)
Class IIActive

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Apr 4, 2023Z-1395-2023—open, classified

Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.