Tahoe Unicompartmental Knee System 55075-00

GUDID 00840286855938

TUKS, Instrument Case 1, Assembly

Shalby Advanced Technologies, Inc.

Instrument tray, reusable
Primary Device ID00840286855938
NIH Device Record Key4845ecdf-7ca2-4470-96f4-3ec4f6a91105
Commercial Distribution StatusIn Commercial Distribution
Brand NameTahoe Unicompartmental Knee System
Version Model Number55075-00
Catalog Number55075-00
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
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286855938 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

[00840286855938]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

On-Brand Devices [Tahoe Unicompartmental Knee System]

00840286846738TUKS, Alignment Rod, 6.4mm x 15" Length
00840286846707Fixation Pin, Tri-Face with Tri-Hub, OC 3.2mm, 2" Long
00840286855969TUKS, TIBIAL PREP GUIDE, DROP ROD ALIGNMENT, ASSY
00840286855952Pin Puller, Assy
00840286855945TUKS, Instrument Case 2, Assembly
00840286855938TUKS, Instrument Case 1, Assembly
00840286859950Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long
00840286848657TUKS, Trial, Tibial Insert, Size 7/8, 14mm
00840286848640TUKS, Trial, Tibial Insert, Size 7/8, 13mm
00840286848633TUKS, Trial, Tibial Insert, Size 7/8, 12mm
00840286848626TUKS, Trial, Tibial Insert, Size 7/8, 11mm
00840286848619TUKS, Trial, Tibial Insert, Size 7/8, 10mm
00840286848602TUKS, Trial, Tibial Insert, Size 7/8, 9mm
00840286848596TUKS, Trial, Tibial Insert, Size 7/8, 8mm
00840286848589TUKS, Trial, Tibial Insert, Size 5/6, 14mm
00840286848572TUKS, Trial, Tibial Insert, Size 5/6, 13mm
00840286848565TUKS, Trial, Tibial Insert, Size 5/6, 12mm
00840286848558TUKS, Trial, Tibial Insert, Size 5/6, 11mm
00840286848541TUKS, Trial, Tibial Insert, Size 5/6, 10mm
00840286848534TUKS, Trial, Tibial Insert, Size 5/6, 9mm
00840286848527TUKS, Trial, Tibial Insert, Size 5/6, 8mm
00840286848510TUKS, Trial, Tibial Insert, Size 3/4, 14mm
00840286848503TUKS, Trial, Tibial Insert, Size 3/4, 13mm
00840286848497TUKS, Trial, Tibial Insert, Size 3/4, 12mm
00840286848480TUKS, Trial, Tibial Insert, Size 3/4, 11mm
00840286848473TUKS, Trial, Tibial Insert, Size 3/4, 10mm
00840286848466TUKS, Trial, Tibial Insert, Size 3/4, 9mm
00840286848459TUKS, Trial, Tibial Insert, Size 3/4, 8mm
00840286848442TUKS, Trial, Tibial Insert, Size 1/2, 14mm
00840286848435TUKS, Trial, Tibial Insert, Size 1/2, 13mm
00840286848428TUKS, Trial, Tibial Insert, Size 1/2, 12mm
00840286848411TUKS, Trial, Tibial Insert, Size 1/2, 11mm
00840286848404TUKS, Trial, Tibial Insert, Size 1/2, 10mm
00840286848398TUKS, Trial, Tibial Insert, Size 1/2, 9mm
00840286848381TUKS, Trial, Tibial Insert, Size 1/2, 8mm
00840286848374TUKS, Trial, Tibial Insert, Size 0, 14mm
00840286848367TUKS, Trial, Tibial Insert, Size 0, 13mm
00840286848350TUKS, Trial, Tibial Insert, Size 0, 12mm
00840286848343TUKS, Trial, Tibial Insert, Size 0, 11mm
00840286848336TUKS, Trial, Tibial Insert, Size 0, 10mm
00840286848329TUKS, Trial, Tibial Insert, Size 0, 9mm
00840286848312TUKS, Trial, Tibial Insert, Size 0, 8mm
00840286848220TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 8
00840286848213TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 7
00840286848206TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 6
00840286848190TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 5
00840286848183TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 4
00840286848176TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 3
00840286848169TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 2
00840286848152TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 1
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