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510(k) K131635

ROTATION MEDICAL BONE STAPLE (RMB STAPLE) by Rotation Medical, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
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 Rotation Medical, Inc.

  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)
  • K131637 — ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) (July 12, 2013)
  • K122048 — COLLAGEN TENDON SHEET-D (January 8, 2013)
  • K112423 — COLLAGEN TENDON SHEET (December 22, 2011)

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