NexGen SSI004657

GUDID 00889024518407

Zimmer, Inc.

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Primary Device ID	00889024518407
NIH Device Record Key	5dd1c33e-d167-45cc-a14d-54b5e76d65d9
Commercial Distribution Status	In Commercial Distribution
Brand Name	NexGen
Version Model Number	SSI004657
Catalog Number	SSI004657
Company DUNS	056038268
Company Name	Zimmer, 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	false
Lot Batch	false
Serial Number	true
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 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com
Phone	1 (800) 343-9500
Email	customerservice@zimmerbiomet.com

Device Dimensions

Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter
Device Size Text, specify	0
Height	10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024518407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152494

FDA Product Code

KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer