04617812

GUDID H981046178120

3.0MM TI CERVICAL SPINE LOCKING SCREW 12MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDH981046178120
NIH Device Record Keya6637661-466a-48d1-9105-93fe125fb12a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.617.812
Catalog Number04617812
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
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
GS110705034742250 [Primary]
HIBCCH981046178120 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

Moist Heat or Steam Sterilization


[H981046178120]

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

10887587078434 - NA2025-07-03 REDUCTION FORCEPS W/ POINTS
10886982343994 - NA2025-07-01 Ø14MM HOLLOW REAMER - FRN
07611819642669 - NA2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819642676 - NA2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819655522 - NA2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
10886982348159 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER
10886982348166 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER
10886982348173 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/175MM/HA STER

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.