C-PS Peek Optima Cervical Interbody Spacer

GUDID M696CPS0812S0

PEEK CERVICAL CAGE 8MM X 12MM

ORTHOPAEDIC IMPLANT COMPANY, THE

Polymeric spinal interbody fusion cage
Primary Device IDM696CPS0812S0
NIH Device Record Key551f069e-d0a8-47c3-8940-dc805de9af91
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-PS Peek Optima Cervical Interbody Spacer
Version Model NumberCPS-0812S
Company DUNS070061160
Company NameORTHOPAEDIC IMPLANT COMPANY, THE
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com

Device Dimensions

Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter
Height8 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM696CPS0812S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

[M696CPS0812S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2017-02-01

On-Brand Devices [C-PS Peek Optima Cervical Interbody Spacer]

M696CPS1015S0PEEK CERVICAL CAGE 10MM X 15MM
M696CPS1012S0PEEK CERVICAL CAGE 10MM X 12MM
M696CPS0915S0PEEK CERVICAL CAGE 9MM X 15MM
M696CPS0912S0PEEK CERVICAL CAGE 9MM X 12MM
M696CPS0815S0PEEK CERVICAL CAGE 8MM X 15MM
M696CPS0812S0PEEK CERVICAL CAGE 8MM X 12MM
M696CPS0715S0PEEK CERVICAL CAGE 7MM X 15MM
M696CPS0712S0PEEK CERVICAL CAGE 7MM X 12MM
M696CPS0615S0PEEK CERVICAL CAGE 6MM X 15MM
M696CPS0612S0PEEK CERVICAL CAGE 6MM X 12MM
M696CPS620S0CERVICAL CAGE INSERTER
M696CPS610S0CERVICAL CAGE SIZER 10MM X 15MM
M696CPS609S0CERVICAL CAGE SIZER 9MM X 15MM
M696CPS608S0CERVICAL CAGE SIZER 8MM X 15MM
M696CPS607S0CERVICAL CAGE SIZER 7MM X 15MM
M696CPS606S0CERVICAL CAGE SIZER 6MM X 15MM
M696CPS605S0CERVICAL CAGE SIZER 10MM X 12MM
M696CPS604S0CERVICAL CAGE SIZER 9MM X 12MM
M696CPS603S0CERVICAL CAGE SIZER 8MM X 12MM
M696CPS602S0CERVICAL CAGE SIZER 7MM X 12MM
M696CPS601S0CERVICAL CAGE SIZER 6MM X 12MM
M696CPS600S0STERILIZATION CASE CERVICAL CAGE SET
M69601CPS020STERILIZATION CASE CERVICAL SPACER COMPLETE
M69601CPS010STERILIZATION CASE CERVICAL SPACER INNER
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