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510(k) K101030

MODIFICATION TO HBS HEADLESS BONE SCREW by Biopro, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2010
Date Received
April 13, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (December 15, 2008)
  • K081149 — BIOPRO GO-EZ SCREW (August 5, 2008)

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