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510(k) K093868

I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM by I.T.S. Implantat-Technologie-Systeme GmbH — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2010
Date Received
December 17, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, 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

  • K080706 — CONNEXX LOCKING TIBIA NAIL (June 9, 2008)
  • 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)

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  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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