Zero-P VA 03647788

GUDID H981036477880

ZERO-P VA TRIAL SPACER W/STOP CONVEX/8MM HEIGHT

Synthes GmbH

Spinal implant trial
Primary Device IDH981036477880
NIH Device Record Keyb188489d-38fc-46f6-b0ba-58363ff33a10
Commercial Distribution StatusIn Commercial Distribution
Brand NameZero-P VA
Version Model Number03.647.788
Catalog Number03647788
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819404311 [Direct Marking]
GS110705034720630 [Primary]
HIBCCH981036477880 [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

[H981036477880]

Moist Heat or Steam Sterilization


[H981036477880]

Moist Heat or Steam Sterilization


[H981036477880]

Moist Heat or Steam Sterilization


[H981036477880]

Moist Heat or Steam Sterilization


[H981036477880]

Moist Heat or Steam Sterilization


[H981036477880]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-06-01
Device Publish Date2015-09-14

On-Brand Devices [Zero-P VA]

H98104647136S0ZERO-P VA IMPLANT 6MM HEIGHT CONVEX-STERILE
07611819404502PACKING BLOCK FOR ZERO-P VA IMPLANTS
H981036477990ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/9MM HEIGHT
H981036477980ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/8MM HEIGHT
H981036477970ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/7MM HEIGHT
H981036477960ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/6MM HEIGHT
H981036477950ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/5MM HEIGHT
H981036477920ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/12MM HEIGHT
H981036477910ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/11MM HEIGHT
H981036477900ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/10MM HEIGHT
H981036477890ZERO-P VA TRIAL SPACER W/STOP CONVEX/9MM HEIGHT
H981036477880ZERO-P VA TRIAL SPACER W/STOP CONVEX/8MM HEIGHT
H981036477870ZERO-P VA TRIAL SPACER W/STOP CONVEX/7MM HEIGHT
H981036477860ZERO-P VA TRIAL SPACER W/STOP CONVEX/6MM HEIGHT
H981036477850ZERO-P VA TRIAL SPACER W/STOP CONVEX/5MM HEIGHT
H981036477820ZERO-P VA TRIAL SPACER W/STOP CONVEX/12MM HEIGHT
H981036477810ZERO-P VA TRIAL SPACER W/STOP CONVEX/11MM HEIGHT
H981036477800ZERO-P VA TRIAL SPACER W/STOP CONVEX/10MM HEIGHT
H981036477690ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/9MM HEIGHT
H981036477680ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/8MM HEIGHT
H981036477670ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/7MM HEIGHT
H981036477660ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/6MM HEIGHT
H981036477650ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/5MM HEIGHT
H981036477620ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/12MM HEIGHT
H981036477610ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/11MM HEIGHT
H981036477600ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/10MM HEIGHT
H981036477590ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/9MM HEIGHT
H981036477580ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/8MM HEIGHT
H981036477570ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/7MM HEIGHT
H981036477560ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/6MM HEIGHT
H981036477550ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/5MM HEIGHT
H981036477520ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/12MM HEIGHT
H981036477510ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/11MM HEIGHT
H981036477500ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/10MM HEIGHT
H981036477380ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/8MM HEIGHT
H981036477370ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/7MM HEIGHT
H981036477360ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/6MM HEIGHT
H981036477350ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/5MM HEIGHT
H981036477320ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/12MM HEIGHT
H981036477310ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/11MM HEIGHT
H981036477300ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/10MM HEIGHT
H981036477290ZERO-P VA TRIAL SPACER W/STOP PARALLEL/9MM HEIGHT
H981036477280ZERO-P VA TRIAL SPACER W/STOP PARALLEL/8MM HEIGHT
H981036477270ZERO-P VA TRIAL SPACER W/STOP PARALLEL/7MM HEIGHT
H981036477260ZERO-P VA TRIAL SPACER W/STOP PARALLEL/6MM HEIGHT
H981036477250ZERO-P VA TRIAL SPACER W/STOP PARALLEL/5MM HEIGHT
H981036477220ZERO-P VA TRIAL SPACER W/STOP PARALLEL/12MM HEIGHT
H981036477210ZERO-P VA TRIAL SPACER W/STOP PARALLEL/11MM HEIGHT
H981036477200ZERO-P VA TRIAL SPACER W/STOP PARALLEL/10MM HEIGHT
H981036477390ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/9MM HEIGHT

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