04614520

GUDID H981046145200

TI TOP LOADING TRANSCONNECTOR X-LARGE

Synthes GmbH

Bone-screw internal spinal fixation system connector

Primary Device ID	H981046145200
NIH Device Record Key	352c5090-f7b5-49d5-ab2a-3b2bffa0cbf4
Commercial Distribution Status	In Commercial Distribution
Version Model Number	04.614.520
Catalog Number	04614520
Company DUNS	486711679
Company Name	Synthes GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034739342 [Primary]
HIBCC	H981046145200 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090549

FDA Product Code

KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

[H981046145200]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2024-08-01
Device Publish Date	2015-09-14

Devices Manufactured by Synthes GmbH

07612334260079 - KINCISE	2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
07612334268587 - KINCISE	2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID
07612334268679 - KINCISE	2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
07612334268563 - KINCISE	2024-11-04 KINCISE™ System Automated Surgical Handpiece V2
07612334268570 - KINCISE	2024-11-04 KINCISE™ System Lithium-ion Battery
07612334268594 - KINCISE	2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
07612334268600 - KINCISE	2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
07612334268617 - KINCISE	2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide

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