Revision Knee System 2472-0-0000

GUDID 00840286823784

Taper Plug

Shalby Advanced Technologies, Inc.

Revision coated hip femur prosthesis
Primary Device ID00840286823784
NIH Device Record Key8eb02aa8-8c32-440a-bf58-6238c396f866
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevision Knee System
Version Model Number2472-0-0000
Catalog Number2472-0-0000
Company DUNS085976260
Company NameShalby Advanced Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286823784 [Primary]

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-31
Device Publish Date2022-01-22

On-Brand Devices [Revision Knee System]

00840286823784Taper Plug
00840286823777Stabilizing Peg, Long
00840286823760Stabilizing Peg, Medium
00840286823753Stabilizing Peg, Short
00840286823722Screw, Flat Head, Long
00840286823715Screw, Flat Head, Short
00840286823708Baseplate Plug
00840286823692Stem, Straight, Cementless, 22mm, 150mm
00840286823685Stem, Straight, Cementless, 20mm, 150mm
00840286823678Stem, Straight, Cementless, 18mm, 150mm
00840286823661Stem, Straight, Cementless, 16mm, 150mm
00840286823654Stem, Straight, Cementless, 14mm, 150mm
00840286823647Stem, Straight, Cementless, 12mm, 150mm
00840286823630Stem, Straight, Cementless, 10mm, 150mm
00840286823623Stem, Straight, Cementless, 22mm, 110mm
00840286823616Stem, Straight, Cementless, 20mm, 110mm
00840286823609Stem, Straight, Cementless, 18mm, 110mm
00840286823593Stem, Straight, Cementless, 16mm, 110mm
00840286823586Stem, Straight, Cementless, 14mm, 110mm
00840286823579Stem, Straight, Cementless, 12mm, 110mm
00840286823562Stem, Straight, Cementless, 10mm, 110mm
00840286823555Stem, Straight, Cementless, 22mm, 80mm
00840286823548Stem, Straight, Cementless, 20mm, 80mm
00840286823531Stem, Straight, Cementless, 18mm, 80mm
00840286823524Stem, Straight, Cementless, 16mm, 80mm
00840286823517Stem, Straight, Cementless, 14mm, 80mm
00840286823500Stem, Straight, Cementless, 12mm, 80mm
00840286823494Stem, Straight, Cementless, 10mm, 80mm
00840286822961Tibial Augment, Cemented, 5 M / 6 L, 10mm
00840286822954Tibial Augment, Cemented, 4 M / 5 L, 10mm
00840286822947Tibial Augment, Cemented, 3 M / 4 L, 10mm
00840286822930Tibial Augment, Cemented, 2 M / 3 L, 10mm
00840286822923Tibial Augment, Cemented, 1 M / 2 L, 10mm
00840286822916Tibial Augment, Cemented, 6 M, 10mm
00840286822909Tibial Augment, Cemented, 0 M / 1 L, 10mm
00840286822893Tibial Augment, Cemented, 0 L, 10mm
00840286822886Tibial Augment, Cemented, 5 M / 6 L, 5mm
00840286822879Tibial Augment, Cemented, 4 M / 5 L, 5mm
00840286822862Tibial Augment, Cemented, 3 M / 4 L, 5mm
00840286822855Tibial Augment, Cemented, 2 M / 3 L, 5mm
00840286822848Tibial Augment, Cemented, 1 M / 2 L, 5mm
00840286822831Tibial Augment, Cemented, 6 M, 5mm
00840286822824Tibial Augment, Cemented, 0 M / 1 L, 5mm
00840286822817Tibial Augment, Cemented, 0 L, 5mm
00840286822800Tibial Baseplate, Cemented, R, 6
00840286822794Tibial Baseplate, Cemented, R, 5
00840286822787Tibial Baseplate, Cemented, R, 4
00840286822770Tibial Baseplate, Cemented, R, 3
00840286822763Tibial Baseplate, Cemented, R, 2
00840286822756Tibial Baseplate, Cemented, R, 1
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.