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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 K100305
Device Name ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER
Applicant
Icotec
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Applicant Contact BARBARA ATZENHOEFER STEGMEIER
Correspondent
Icotec
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Correspondent Contact BARBARA ATZENHOEFER STEGMEIER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/03/2010
Decision Date 07/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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