FIX-C PEEK Anterior Cervical Interbody System

GUDID 08800089425891

Jeil Medical Corporation

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

Primary Device ID	08800089425891
NIH Device Record Key	3c926807-b885-4b71-8182-51f5aa25ee5e
Commercial Distribution Status	In Commercial Distribution
Brand Name	FIX-C PEEK Anterior Cervical Interbody System
Version Model Number	C1-PCGL-09
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	08800089425891 [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

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

[08800089425891]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-19
Device Publish Date	2022-01-11

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

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