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510(k) K131637

ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) by Rotation Medical, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Rotation Medical, Inc.

  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)
  • K131635 — ROTATION MEDICAL BONE STAPLE (RMB STAPLE) (August 29, 2013)
  • K122048 — COLLAGEN TENDON SHEET-D (January 8, 2013)
  • K112423 — COLLAGEN TENDON SHEET (December 22, 2011)

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