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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 K171519
Device Name FLXfit™
Applicant
Expanding Orthopedics, Inc.
3379 Peachtree Road NE (Buckhead), Suite 555
Atlanta,  GA  30326
Applicant Contact Ofer Bokobza
Correspondent
Empirical Technologies Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/24/2017
Decision Date 09/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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