FDA.reportPublic FDA data

Distal Fibula Plating System

Primary DI
B471126600110
Brand
Distal Fibula Plating System
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
12660011
Device description
Distal Fibula Plate Deep Syndesmosis Fixation Holes, 11-Hole
Published
2022-01-10
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
HRSPlate, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B471126600110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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
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
B471120201050FirstFUSE 1st MTP Joint Plating System120201052020-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
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10886982350848VOLTSynthes GmbHHRS2026-09-25
10886982350855VOLTSynthes GmbHHRS2026-09-25
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10886982350879VOLTSynthes GmbHHRS2026-09-25