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510(k) K163627

Shotel Ankle Arthrodesis Nail System by Biopro, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2017
Date Received
December 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Biopro, Inc.

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  • K130298 — BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM (June 18, 2013)
  • K121973 — BIOPRO HEMI-EDGE TOE SYSTEM (October 30, 2012)
  • K100761 — BIOPRO POLAR HEAD (December 3, 2010)
  • K101030 — MODIFICATION TO HBS HEADLESS BONE SCREW (June 3, 2010)
  • K090208 — BIOPRO FEMORAL HEADS (May 22, 2009)
  • K083490 — BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 (March 18, 2009)
  • K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (December 15, 2008)
  • K081149 — BIOPRO GO-EZ SCREW (August 5, 2008)

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