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510(k) K040212

TRIGEN INTERTAN by Smith & Nephew, Inc. — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
January 30, 2004
Clearance Type
Special
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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  • K193533 — WIN Flexible Nail System (February 20, 2020)
  • K141737 — CONVENTUS PHS SYSTEM (April 8, 2015)
  • K123948 — CHINA NAILS AND ACCESSORIES (March 14, 2013)