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510(k) K011459

WUJIN #3 FEMORAL BONE PLATE by Biopro, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2001
Date Received
May 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
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)

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