FDA.report

Responsive Orthopedics Total Knee Arthroplasty System

Primary DI
00841973108375
Brand
Responsive Orthopedics Total Knee Arthroplasty System
Company
RESPONSIVE ORTHOPEDICS, LLC
Model
90-SRK-800011
Catalog number
90-SRK-800011
Device description
Poly Trials - CR Case
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841973108375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841973108375008419731083758419731083750841973108375

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080074787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841973100003Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3121002016-03-04
00841973100010Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3111002016-03-04
00841973100027Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3122002016-03-04
00841973100034Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3112002016-03-04
00841973100041Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3123002016-03-04
00841973100058Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3113002016-03-04
00841973100065Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3124002016-03-04
00841973100072Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3114002016-03-04
00841973100089Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3125002016-03-04
00841973100096Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3115002016-03-04
00841973100102Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3126002016-03-04
00841973100119Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3116002016-03-04
00841973100126Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3321002016-03-04
00841973100133Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3311002016-03-04
00841973100140Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3322002016-03-04
00841973100157Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3312002016-03-04
00841973100164Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3323002016-03-04
00841973100171Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3313002016-03-04
00841973100188Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3324002016-03-04
00841973100195Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3314002016-03-04

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Primary DIBrandCompanyProduct codePublished
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00889024706811Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00843575127143MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
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