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510(k) K193533

WIN Flexible Nail System by Biomet, Inc. — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2020
Date Received
December 20, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nail, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K230761 — TRIGEN META-NAIL Nail System (June 14, 2023)
  • K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails (September 3, 2020)
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  • K141737 — CONVENTUS PHS SYSTEM (April 8, 2015)
  • K123948 — CHINA NAILS AND ACCESSORIES (March 14, 2013)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)