C-PS Peek Optima Cervical Interbody Spacer

GUDID M696CPS604S0

CERVICAL CAGE SIZER 9MM X 12MM

ORTHOPAEDIC IMPLANT COMPANY, THE

Spinal implant trial

• Primary Device ID: M696CPS604S0
• NIH Device Record Key: 21c160d0-4330-402d-bd6d-e7742cba4ca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-PS Peek Optima Cervical Interbody Spacer
• Version Model Number: CPS-604S
• Company DUNS: 070061160
• Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M696CPS604S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092540

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

[M696CPS604S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-01
• Device Publish Date: 2017-02-01

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

• M696CPS1015S0: PEEK CERVICAL CAGE 10MM X 15MM
• M696CPS1012S0: PEEK CERVICAL CAGE 10MM X 12MM
• M696CPS0915S0: PEEK CERVICAL CAGE 9MM X 15MM
• M696CPS0912S0: PEEK CERVICAL CAGE 9MM X 12MM
• M696CPS0815S0: PEEK CERVICAL CAGE 8MM X 15MM
• M696CPS0812S0: PEEK CERVICAL CAGE 8MM X 12MM
• M696CPS0715S0: PEEK CERVICAL CAGE 7MM X 15MM
• M696CPS0712S0: PEEK CERVICAL CAGE 7MM X 12MM
• M696CPS0615S0: PEEK CERVICAL CAGE 6MM X 15MM
• M696CPS0612S0: PEEK CERVICAL CAGE 6MM X 12MM
• M696CPS620S0: CERVICAL CAGE INSERTER
• M696CPS610S0: CERVICAL CAGE SIZER 10MM X 15MM
• M696CPS609S0: CERVICAL CAGE SIZER 9MM X 15MM
• M696CPS608S0: CERVICAL CAGE SIZER 8MM X 15MM
• M696CPS607S0: CERVICAL CAGE SIZER 7MM X 15MM
• M696CPS606S0: CERVICAL CAGE SIZER 6MM X 15MM
• M696CPS605S0: CERVICAL CAGE SIZER 10MM X 12MM
• M696CPS604S0: CERVICAL CAGE SIZER 9MM X 12MM
• M696CPS603S0: CERVICAL CAGE SIZER 8MM X 12MM
• M696CPS602S0: CERVICAL CAGE SIZER 7MM X 12MM
• M696CPS601S0: CERVICAL CAGE SIZER 6MM X 12MM
• M696CPS600S0: STERILIZATION CASE CERVICAL CAGE SET
• M69601CPS020: STERILIZATION CASE CERVICAL SPACER COMPLETE
• M69601CPS010: STERILIZATION CASE CERVICAL SPACER INNER