FDA.reportPublic FDA data

Responsive Orthopedics Total Knee Arthroplasty System

Primary DI
00841973108443
Brand
Responsive Orthopedics Total Knee Arthroplasty System
Company
RESPONSIVE ORTHOPEDICS, LLC
Model
90-SRK-800031
Catalog number
90-SRK-800031
Device description
Femoral Trials - CR/CS Case
Published
2016-09-15
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841973108443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841973108443008419731084438419731084430841973108443

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080074787
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841973105992Responsive Orthopedics Total Knee Arthroplasty System90-SRK-30041090-SRK-3004102016-09-01
00841973106005Responsive Orthopedics Total Knee Arthroplasty System90-SRK-30042090-SRK-3004202016-09-01
00841973106135Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20130090-SRK-2013002016-09-02
00841973106159Responsive Orthopedics Total Knee Arthroplasty System90-SRK-10000090-SRK-1000002016-09-02
00841973105985Responsive Orthopedics Total Knee Arthroplasty System90-SRK-30040090-SRK-3004002016-09-01
00841973106142Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20131090-SRK-2013102016-09-02
00841973106166Responsive Orthopedics Total Knee Arthroplasty System90-SRK-10001090-SRK-1000102016-09-03
00841973108368Responsive Orthopedics Total Knee Arthroplasty System90-SRK-10005090-SRK-1000502016-09-01
00841973108375Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001190-SRK-8000112016-09-14
00841973108382Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001290-SRK-8000122016-09-14
00841973108399Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001390-SRK-8000132016-09-14
00841973108405Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001490-SRK-8000142016-09-14
00841973108412Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001590-SRK-8000152016-09-15
00841973108429Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80002090-SRK-8000202016-09-15
00841973108436Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80003090-SRK-8000302016-09-15
00841973108450Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80003390-SRK-8000332016-09-15
00841973108467Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80004090-SRK-8000402016-09-15
00841973106111Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20122190-SRK-2012212016-09-02
00841973106128Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20122290-SRK-2012222016-09-02
00841973106234Responsive Orthopedics Total Knee Arthroplasty System90-SRK-35111190-SRK-3511112016-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24