FDA.reportPublic FDA data

OrthoMedFlex

Primary DI
M7161124411080
Brand
OrthoMedFlex
Company
ORTHOMEDFLEX LLC
Model
112-44-1108
Device description
Origin R Broach Size 8
Published
2021-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTQBroach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7161124411080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-844-663-3540info@orthomedflex.com

Regulatory Flags#

DUNS number
034442726
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7161011020OrthoMedFlex101-1021011022016-08-30
M7161011250OrthoMedFlex101-125101-1252016-08-29
M7161011260OrthoMedFlex101-126101-1262016-08-29
M7161011340OrthoMedFlex101-134101-1342016-08-30
M7161011430OrthoMedFlex, LLC101-143101-1432017-09-19
M716101164280OrthoMedFlex101-164-28101-164-282016-08-29
M716101164360OrthoMedFlex101-164-36101-164-362016-08-29
M7161011710OrthoMedFlex101-171101-1712016-08-29
M7161012260OrthoMedFlex101-226101-2262016-09-01
M7161012290OrthoMedFlex101229101-2292017-03-07
M7161012400OrthoMedFlex101240101-2402017-10-03
M7161012430OrthoMedFlex101-243101-2432021-06-24
M7161013010OrthoMedFlex101-301101-3012016-08-31
M7161013020OrthoMedFlex101-302101-3022016-08-31
M7161013040OrthoMedFlex, LLC101-304101-3042017-04-25
M7161013190OrthoMedFlex101-319101-3192016-08-29
M7161013190210OrthoMedFlex101319021101-319-0212017-02-23
M7161013310OrthoMedFlex, LLC101-331101-3312017-09-19
M7161013510OrthoMedFlex101-351101-3512016-08-31
M7161013520OrthoMedFlex, LLC101-352101-3522017-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
10603295079965AML EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080176EXCEL TRI-LOCKDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080183EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080190EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080206EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080213EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080220EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080237EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080244EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080251NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080268NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080275EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080282EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080299EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080305EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080312EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080329EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24