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510(k) K072095

SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS by Synthes (Usa) — Product Code JDS

K072095 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS". The FDA issued a decision of Substantially Equivalent on September 27, 2007. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2007
Date Received
July 31, 2007
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 Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

Other clearances for product code JDS

  • K243608 — TRIGEN Stable Lock Nut & Washer (June 12, 2025)
  • 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)

FDA data resources