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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 K133455
Device Name CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Applicant Contact EMILY DOWNS
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Correspondent Contact EMILY DOWNS
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received11/12/2013
Decision Date 03/27/2014
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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