Revision Knee System 2970-0-0020

GUDID 00840286843133

RKS, Assembly, Bottom, Tibial Alignment Guide

Shalby Advanced Technologies, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00840286843133
NIH Device Record Key4b69cd63-83e8-4769-8465-4cdbef931abd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevision Knee System
Version Model Number2970-0-0020
Catalog Number2970-0-0020
Company DUNS085976260
Company NameShalby Advanced Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286843133 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

[00840286843133]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-22
Device Publish Date2025-05-14

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
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