TaperSet Hip System 1911-2-1075

GUDID 00840286840644

TaperSet, Trial Neck, Lat., Size 7.5mm & 9mm

Shalby Advanced Technologies, Inc.

Femoral stem prosthesis trial
Primary Device ID00840286840644
NIH Device Record Keyafcbd0dc-8495-45f0-a8cf-24538fe130e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTaperSet Hip System
Version Model Number1911-2-1075
Catalog Number1911-2-1075
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286840644 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

Moist Heat or Steam Sterilization

[00840286840644]

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 [TaperSet Hip System]

00840286856119TaperSet, Broach, Size 24mm
00840286856102TaperSet, Broach, Size 21mm
00840286856096TaperSet, Broach, Size 18.5mm
00840286856089TaperSet, Broach, Size 16.5mm
00840286856072TaperSet, Broach, Size 15mm
00840286856065TaperSet, Broach, Size 13.5mm
00840286856058TaperSet, Broach, Size 12mm
00840286856041TaperSet, Broach, Size 10.5mm
00840286856034Taperset Calcar Cutter, Directional Teeth, Large
00840286856027Taperset Calcar Cutter, Directional Teeth, Small
00840286856010TaperSet, Calcar Cutter, Large
00840286856003TaperSet, Calcar Cutter, Medium
00840286855990TaperSet, Calcar Cutter, Small
00840286855983TaperSet, Osteotome, Modular
00840286840743TaperSet, Trial Neck, Std., Size 21mm & 24mm
00840286840736TaperSet, Trial Neck, Std., Size 16.5mm & 18.5mm
00840286840729TaperSet, Trial Neck, Std., Size 13.5mm & 15mm
00840286840712TaperSet, Trial Neck, Std., Size 10.5mm & 12mm
00840286840705TaperSet, Trial Neck, Std., Size 7.5mm & 9mm
00840286840699TaperSet, Trial Neck, Std, Size 5mm & 6mm
00840286840682TaperSet, Trial Neck, Lat., Size 21mm & 24mm
00840286840675TaperSet, Trial Neck, Lat., Size 16.5mm & 18.5mm
00840286840668TaperSet, Trial Neck, Lat., Size 13.5mm & 15mm
00840286840651TaperSet, Trial Neck, Lat., Size 10.5mm & 12mm
00840286840644TaperSet, Trial Neck, Lat., Size 7.5mm & 9mm
00840286840637TaperSet, Trial Neck, Lat., Size 5mm & 6mm
00840286840477TaperSet, Broach Holder, Assembly
00840286840453TaperSet, Instrument Case
00840286841009Taperset Calcar Cutter, Directional Teeth, Medium
00840286840996TaperSet, Assembly, Stem Impactor, Offset, Non-Threaded
00840286840958TaperSet, Assembly, Stem Impactor
00840286840620TaperSet, RDP, Broach, 24mm
00840286840613TaperSet, RDP, Broach, 21mm
00840286840606TaperSet, RDP, Broach, 18.5mm
00840286840590TaperSet, RDP, Broach, 16/5mm
00840286840583TaperSet, RDP, Broach, 15mm
00840286840576TaperSet, RDP, Broach, 13.5mm
00840286840569TaperSet, RDP, Broach, 12mm
00840286840545TaperSet, Broach, Size 9mm
00840286840538TapserSet, Broach, Size 7.5mm
00840286840521TaperSet, Broach, STD, 6mm
00840286840514TaperSet, Broach, STD, 5mm
00840286840507TaperSet, Mini Broach
00840286840491TaperSet, Rasp
00840286840460TaperSet, Resection Guide
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