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510(k) K002325

WUJIN #3 TIBIAL NAIL by Biologically Oriented Prostheses — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2000
Date Received
August 1, 2000
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

Other clearances by Biologically Oriented Prostheses

  • K992144 — BIOPRO RIMMED ACETABULAR COMPOMENT (September 22, 1999)
  • K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT (February 3, 1997)
  • K962769 — HORIZON HIP SYSTEM (October 3, 1996)
  • K955916 — TOWNLEY TOTAL ELBOW SYSTEM (August 8, 1996)
  • K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (January 18, 1996)
  • K952731 — TOWNLEY ALL POLY ACETABULAR CUP (December 28, 1995)
  • K953045 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (September 27, 1995)
  • K951356 — VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED (June 19, 1995)

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  • K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (September 20, 2024)
  • K241804 — TRIGEN INTERTAN 10S Nail System (August 22, 2024)
  • K233150 — NET BRAND Osteosynthesis Nailing System (February 20, 2024)
  • K230761 — TRIGEN META-NAIL Nail System (June 14, 2023)
  • K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails (September 3, 2020)
  • K192003 — Auxein Nailing System (June 10, 2020)
  • K193533 — WIN Flexible Nail System (February 20, 2020)
  • K141737 — CONVENTUS PHS SYSTEM (April 8, 2015)
  • K123948 — CHINA NAILS AND ACCESSORIES (March 14, 2013)