FIX-C PEEK Anterior Cervical Interbody System

GUDID 08800089425181

Jeil Medical Corporation

Polymeric spinal interbody fusion cage

• Primary Device ID: 08800089425181
• NIH Device Record Key: 3b13b2b2-5e0f-424c-b65a-b2cebef1f640
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIX-C PEEK Anterior Cervical Interbody System
• Version Model Number: SC1-LCGS-08
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800089425181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212266

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

[08800089425181]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-18
• Device Publish Date: 2022-01-10

On-Brand Devices [FIX-C PEEK Anterior Cervical Interbody System]

• 08806390888684: C1-CCGS-09
• 08806390888677: C1-CCGS-08
• 08806390888660: C1-CCGS-07
• 08806390888653: C1-CCGS-06
• 08806390888646: C1-CCGS-05
• 08806390888639: C1-CCGS-04
• 08806390888622: C1-CCGM-09
• 08806390888615: C1-CCGM-08
• 08806390888608: C1-CCGM-07
• 08806390888592: C1-CCGM-06
• 08806390888585: C1-CCGM-05
• 08806390888578: C1-CCGM-04
• 08806390888561: C1-CCGL-09
• 08806390888554: C1-CCGL-08
• 08806390888547: C1-CCGL-07
• 08806390888530: C1-CCGL-06
• 08806390888523: C1-CCGL-05
• 08806390888516: C1-CCGL-04
• 08800089425594: SC1-CCGM-11
• 08800089425587: SC1-CCGM-10
• 08800089425570: SC1-CCGM-09
• 08800089425563: SC1-CCGM-08
• 08800089425556: SC1-CCGM-07
• 08800089425549: SC1-CCGM-06
• 08800089425532: SC1-CCGM-05
• 08800089425525: SC1-CCGM-04
• 08800089425518: SC1-CCGS-11
• 08800089425501: SC1-CCGS-10
• 08800089425495: SC1-CCGS-09
• 08800089425488: SC1-CCGS-08
• 08800089425471: SC1-CCGS-07
• 08800089425464: SC1-CCGS-06
• 08800089425457: SC1-CCGS-05
• 08800089425440: SC1-CCGS-04
• 08800089425433: C1-CCGL-11
• 08800089425426: C1-CCGL-10
• 08800089425419: C1-CCGM-11
• 08800089425402: C1-CCGM-10
• 08800089425396: C1-CCGS-11
• 08800089425389: C1-CCGS-10
• 08800089425372: SC1-LCGL-11
• 08800089425365: SC1-LCGL-10
• 08800089425358: SC1-LCGL-09
• 08800089425341: SC1-LCGL-08
• 08800089425334: SC1-LCGL-07
• 08800089425327: SC1-LCGL-06
• 08800089425310: SC1-LCGL-05
• 08800089425303: SC1-LCGL-04
• 08800089425297: SC1-LCGM-11
• 08800089425280: SC1-LCGM-10