ZERO-P NATURAL 04617708S

GUDID H98104617708S0

ZERO-P NATURAL PLATE SIZE 8 WITH ASSEMBLY TOOL-STERILE

Synthes GmbH

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

Primary Device ID	H98104617708S0
NIH Device Record Key	97aa9612-11fc-40a7-ae41-7598c030eb74
Commercial Distribution Status	In Commercial Distribution
Brand Name	ZERO-P NATURAL
Version Model Number	04.617.708S
Catalog Number	04617708S
Company DUNS	486711679
Company Name	Synthes GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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	true
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034811680 [Primary]
HIBCC	H98104617708S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152239

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2022-04-27
Device Publish Date	2016-06-30

On-Brand Devices [ZERO-P NATURAL]

H98103617014S0	ZERO-P NATURAL ASSEMBLY TOOL STERILE
07612334096906	ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/10MM
07612334096722	ZERO-P NATURAL TRIAL SPACER PARALLEL/10MM
H98104617712S0	ZERO-P NATURAL PLATE SIZE 12 WITH ASSEMBLY TOOL-STERILE
H98104617711S0	ZERO-P NATURAL PLATE SIZE 11 WITH ASSEMBLY TOOL-STERILE
H98104617710S0	ZERO-P NATURAL PLATE SIZE 10 WITH ASSEMBLY TOOL-STERILE
H98104617709S0	ZERO-P NATURAL PLATE SIZE 9 WITH ASSEMBLY TOOL-STERILE
H98104617708S0	ZERO-P NATURAL PLATE SIZE 8 WITH ASSEMBLY TOOL-STERILE
H98104617707S0	ZERO-P NATURAL PLATE SIZE 7 WITH ASSEMBLY TOOL-STERILE
H98104617706S0	ZERO-P NATURAL PLATE SIZE 6 WITH ASSEMBLY TOOL-STERILE
07612334097132	ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/9MM
07612334097125	ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/8MM
07612334097118	ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/7MM
07612334097101	ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/6MM
07612334097088	ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/12MM
07612334097071	ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/11MM
07612334097064	ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/10MM
07612334097057	ZERO-P NATURAL TRIAL SPACER LORDOTIC/9MM
07612334097040	ZERO-P NATURAL TRIAL SPACER LORDOTIC/8MM
07612334097033	ZERO-P NATURAL TRIAL SPACER LORDOTIC/7MM
07612334097026	ZERO-P NATURAL TRIAL SPACER LORDOTIC/6MM
07612334097002	ZERO-P NATURAL TRIAL SPACER LORDOTIC/12MM
07612334096999	ZERO-P NATURAL TRIAL SPACER LORDOTIC/11MM
07612334096982	ZERO-P NATURAL TRIAL SPACER LORDOTIC/10MM
07612334096975	ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/9MM
07612334096968	ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/8MM
07612334096951	ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/7MM
07612334096944	ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/6MM
07612334096920	ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/12MM
07612334096913	ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/11MM
07612334096890	ZERO-P NATURAL TRIAL SPACER PARALLEL/9MM
07612334096883	ZERO-P NATURAL TRIAL SPACER PARALLEL/8MM
07612334096876	ZERO-P NATURAL TRIAL SPACER PARALLEL/7MM
07612334096869	ZERO-P NATURAL TRIAL SPACER PARALLEL/6MM
07612334096746	ZERO-P NATURAL TRIAL SPACER PARALLEL/12MM
07612334096739	ZERO-P NATURAL TRIAL SPACER PARALLEL/11MM