FDA.reportPublic FDA data

AMF REVISION TT CONES

Primary DI
08033390217590
Brand
AMF REVISION TT CONES
Company
LIMACORPORATE SPA
Model
906C.05.A17
Catalog number
906C.05.A17
Device description
AMF TT Cones - Canal Reamer Dia. 17 mm
Published
2022-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200653000AMF Revision TT ConesLima Corporate S.P.A.2020-05-07JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390217590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390217590080333902175908033390217590

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic reamer guideAn orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joint (e.g., the condyle head of the knee, the olecranon of the ulna) or for the reaming of the intramedullary canal for acceptance of an intramedullary nail. The device allows the controlled cutting action of the reamer which is steered down its length. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
432066322
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19
08033390002257SMR System1362.09.0201362.09.0202026-02-19
08033390050029SMR System1362.09.1151362.09.1152026-02-19
08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
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00193982533670ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14