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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K171495
Device Name Zyston Strut Open Titanium Spacer System
Applicant
Zimmer Biomet Spine Inc.
10225 Westmoor Drive
westminster,  CO  80021
Applicant Contact megan fessenden
Correspondent
Zimmer Biomet Spine Inc.
10225 Westmoor Drive
westminster,  CO  80021
Correspondent Contact megan fessenden
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/22/2017
Decision Date 02/12/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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