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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K120942
Device Name PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
Applicant
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Applicant Contact PAUL VAGTS
Correspondent
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Correspondent Contact PAUL VAGTS
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/29/2012
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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