FDA.reportPublic FDA data

GEO Staple System

Primary DI
B471141111520
Brand
GEO Staple System
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
14111152
Device description
Staple 11mmx15mmx13mm, Asymmetric Barbed Leg, Nitinol
Published
2019-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B471141111520PrimaryHIBCC0

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
Width11Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
B471110235420EPS Plating System Screw110235422022-01-10
B471110235440EPS Plating System Screw110235442022-01-10
B471110235460EPS Plating System Screw110235462022-01-10
B471110235480EPS Plating System Screw110235482022-01-10
B471110235500EPS Plating System Screw110235502022-01-10
B471110235550EPS Plating System Screw110235552022-01-10
B471110235600EPS Plating System Screw110235602022-01-10
B471110340420EPS Plating System Screw110340422022-01-10
B471110340440EPS Plating System Screw110340442022-01-10
B471110340460EPS Plating System Screw110340462022-01-10
B471110340480EPS Plating System Screw110340482022-01-10
B471110340500EPS Plating System Screw110340502022-01-10
B471110340550EPS Plating System Screw110340552022-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060267134523Fastlok 8mm x 23mmXIROS LTDJDR2026-02-16
05060267134530Fastlok 6mm x 23mmXIROS LTDJDR2026-02-16
10193489020892MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
10193489020915MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
10193489020946MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
00810111225236Lapiplasty SpeedPlate - TMTTreace Medical Concepts, Inc.JDR2026-01-23
00810135964180VertexNVISION BIOMEDICAL TECHNOLOGIES, INC.JDR2025-12-17
00810111224918TMC FastPitch ScrewsTreace Medical Concepts, Inc.JDR2025-12-12
00810111225175TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225199TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225373TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111224857TMC SpeedMTPTreace Medical Concepts, Inc.JDR2025-11-14
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
00854325007004Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007011Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007028Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007035Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007042Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007059Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007066Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007073Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007080Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007097Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007103Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007110Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007127Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007134Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007141Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007158Reign MedicalF & A Foundation LLCJDR2025-09-05