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510(k) K210043

LOQTEQ Distal Lateral Femur Plate 4.5 System by Aap Implantate AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2021
Date Received
January 7, 2021
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 Aap Implantate AG

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  • K211582 — LOQTEQ Proximal Humerus Plate 3.5 System (October 18, 2021)
  • 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)
  • K150974 — aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Tita (April 29, 2015)

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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)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)