FDA.reportPublic FDA data

OrthoMedFlex, LLC

Primary DI
M7161011350
Brand
OrthoMedFlex, LLC
Company
ORTHOMEDFLEX LLC
Model
101-135
Catalog number
101-135
Device description
IM Drill Reamer
Published
2017-09-19
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
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7161011350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-844-663-3539info@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
10886982362858NASynthes GmbHHTO2026-08-21
10886982362865NASynthes GmbHHTO2026-08-21
10886982362872NASynthes GmbHHTO2026-08-21
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464052VersiTomic 2-Fluted Cannulated Reamer Ø12.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
10810128464069VersiTomic 2-Fluted Cannulated Reamer Ø13.0mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00190376544502InvictusALPHATEC SPINE, INC.HTO2026-07-30
03701089526364AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526371AMPLITUDEAMPLITUDE SASHTO2026-07-29
03701089526388AMPLITUDEAMPLITUDE SASHTO2026-07-29
03700569676636Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676643Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
03700569676650Newclip InstrumentsNEWCLIP TECHNICSHTO2026-07-28
18059015378320Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378337Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378344Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23
18059015378351Flexible Reamers SystemORTHOFIX SRLHTO2026-07-23