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510(k) K080706

CONNEXX LOCKING TIBIA NAIL by I.T.S. Implantat-Technologie-Systeme GmbH — Product Code JDS

K080706 is an FDA 510(k) premarket notification submitted by I.T.S. Implantat-Technologie-Systeme GmbH for the device "CONNEXX LOCKING TIBIA NAIL". The FDA issued a decision of Substantially Equivalent on June 9, 2008. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. I.T.S. Implantat-Technologie-Systeme GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2008
Date Received
March 12, 2008
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 I.T.S. Implantat-Technologie-Systeme GmbH

  • K093868 — I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM (August 5, 2010)
  • K080184 — DISTAL HUMERAL PLATES WITH ANGULAR STABILITY (March 26, 2008)
  • K063672 — FIBULA PLATE PROLOCK WITH ANGULAR STABILITY (February 2, 2007)
  • K063166 — I.T.S. PELVIC RECONSTRUCTION SYSTEM (December 22, 2006)
  • K060156 — STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM (March 20, 2006)
  • K052368 — OLECRANONPLATE WITH ANGULAR STABILITY (October 17, 2005)
  • K051642 — FR.O.H. CALCANEUS REPAIR SYSTEM (August 22, 2005)
  • K052011 — PILONPLATE WITH ANGULAR STABILITY (August 10, 2005)
  • K051412 — HUMERAL HEAD PLATE WITH ANGULAR STABILITY (July 11, 2005)
  • K050852 — CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM (June 22, 2005)

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