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510(k) K111471

EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) by Medshape Solutions, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2011
Date Received
May 27, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Medshape Solutions, Inc.

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  • K101808 — SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOF (November 8, 2010)
  • K092914 — WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES (December 9, 2009)
  • K091202 — WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB V (September 16, 2009)
  • K083792 — WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 (March 25, 2009)

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