SD09633187

GUDID H981SD096331870

5.5MM/6.0MM TAPERED ROD 500MM (400MM/100MM)

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDH981SD096331870
NIH Device Record Key963506f4-522f-45a5-bb67-b3c99a6975e5
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD09.633.187
Catalog NumberSD09633187
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034705354 [Primary]
HIBCCH981SD096331870 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


[H981SD096331870]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-26
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

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07612334268587 - KINCISE2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID
07612334268679 - KINCISE2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
07612334268563 - KINCISE2024-11-04 KINCISE™ System Automated Surgical Handpiece V2
07612334268570 - KINCISE2024-11-04 KINCISE™ System Lithium-ion Battery
07612334268594 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
07612334268600 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
07612334268617 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide

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