FDA.reportPublic FDA data

GEO Staple System

Primary DI
B471141181830
Brand
GEO Staple System
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
14118183
Device description
Staple 18mmx18mmx15mm, Asymmetric Barbed Leg, Nitinol
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRStaple, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B471141181830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width18Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)436-2278GEOSupportCenter@gramercyortho.com

Regulatory Flags#

DUNS number
080068420
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B471120301040Lapidus Plating System120301042023-07-17
B471120302050Lapidus Plating System120302052023-07-17
B471120303050Lapidus Plating System120303052023-07-17
B471123301040Lapidus Plating System123301042023-07-17
B471123302050Lapidus Plating System123302052023-07-17
B471123303050Lapidus Plating System123303052023-07-17
B471126300040Lapidus Plating System126300042023-07-17
B471126600050Distal Fibula Plating System126600052022-01-10
B471126600070Distal Fibula Plating System126600072022-01-10
B471126600090Distal Fibula Plating System126600092022-01-10
B471126600110Distal Fibula Plating System126600112022-01-10
B471126601050Distal Fibula Plating System126601052022-01-10
B471126601070Distal Fibula Plating System126601072022-01-10
B471126601090Distal Fibula Plating System126601092022-01-10
B471126601110Distal Fibula Plating System126601112022-01-10
B471120200000FirstFUSE 1st MTP Joint Plating System120200002020-10-23
B471120200050FirstFUSE 1st MTP Joint Plating System120200052020-10-23
B471120200500FirstFUSE 1st MTP Joint Plating System120200502020-10-23
B471120200550FirstFUSE 1st MTP Joint Plating System120200552020-10-23
B471120201000FirstFUSE 1st MTP Joint Plating System120201002020-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.JDR2026-03-30
00810111224833TMC Nanoplasty SystemTreace Medical Concepts, Inc.JDR2025-10-10
00811714036458Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
00811714036465Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
07630037889397APTUSMedartis AGJDR2023-03-03
10888867042633Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042640Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042671Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042688Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
00811714035345Thunderbolt Suture AssemblyRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
00811714035352Thunderbolt PlateRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
07630971238039MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238046MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238053MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238060MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238077MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238084MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238091MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238107MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238114MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238121MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
00815432025138MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2018-08-06