LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5 …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161747

Identifiers

510(k) Number: K161747 FDA 510(k)
FDA Product Code: HRS FDA 510(k)
Models / Variants: LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5 FDA 510(k)
LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5 FDA 510(k)
LOQTEQ® VA Distal Fibula Plate 2.7/3.5 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 888.3030 FDA 510(k)
Regulation Number: 888.3030 FDA 510(k)
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5 … by aap Implantate AG — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K161747	Class II	Active

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Manufacturer

Manufacturer: aap Implantate AG

Sources (1)

FDA 510(k) K161747 24 fields · synced Jun 18, 2026