04633371

GUDID H981046333710

5.5MM TI HARD PRECONTOURED ROD 65MM STRAIGHT LENGTH/400MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDH981046333710
NIH Device Record Key746590e8-b033-417b-b799-2c8cec9c420c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.633.371
Catalog Number04633371
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
GS110705034746708 [Primary]
HIBCCH981046333710 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

Moist Heat or Steam Sterilization


[H981046333710]

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

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10886982349835 - NA2025-07-24 WRENCH / 11MM SLOTTED SOCKET
10886982350121 - NA2025-07-24 FEMORAL GONIOMETER
10886982350152 - NA2025-07-24 5TH MET WIRE GUIDE
10886982350428 - NA2025-07-24 TENS BENDING EXTRACTOR
10886982348326 - NA2025-07-08 SCREW RACK 3.0 & 4.0
10887587078434 - NA2025-07-03 REDUCTION FORCEPS W/ POINTS
10886982343994 - NA2025-07-01 Ø14MM HOLLOW REAMER - FRN

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