04633187

GUDID H981046331870

5.5MM/6.0MM TI HARD TAPERED ROD 500MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDH981046331870
NIH Device Record Keydf7d9fbb-0685-4641-9f99-72db5600c111
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.633.187
Catalog Number04633187
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
GS110705034746357 [Primary]
HIBCCH981046331870 [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

[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

Moist Heat or Steam Sterilization


[H981046331870]

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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10886982313706 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313713 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313720 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE
10886982313737 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313744 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313751 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313768 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE

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