CAPRI Corpectomy Cage System 2101-22625L0

GUDID 10888857031807

External Housing

K2M, INC.

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

Primary Device ID	10888857031807
NIH Device Record Key	372c3872-98cb-44c0-8479-ed7499d070a5
Commercial Distribution Status	In Commercial Distribution
Brand Name	CAPRI Corpectomy Cage System
Version Model Number	2101-22625L0
Catalog Number	2101-22625L0
Company DUNS	146060863
Company Name	K2M, INC.
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	false
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	+1(703)777-3155
Email	sgilbert@k2m.com
Phone	+1(703)777-3155
Email	sgilbert@k2m.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com

Device Dimensions

Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter
Length	21 Millimeter
Device Size Text, specify	0
Width	25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857031807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142016

FDA Product Code

MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE