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510(k) K133675

AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 by Aap Implantate AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2014
Date Received
November 29, 2013
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

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  • K182818 — LOQTEQ VA Calcaneus Plate 3.5 (August 1, 2019)
  • K182785 — LOQTEQ VA Foot Plates 2.5 (June 19, 2019)
  • K161696 — aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 (November 23, 2016)
  • K161747 — LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; (November 22, 2016)
  • K161703 — LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer (November 4, 2016)
  • K153034 — aap LOQTEQ VA Radius Set 2.5 (January 21, 2016)

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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)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
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