LOQTEQ® VA Proximal Humerus Plate 3.5— 510(k) K254253
Substantially EquivalentAap Implantate AG
FDA 510(k) clearance K254253 for LOQTEQ® VA Proximal Humerus Plate 3.5, Substantially Equivalent on 2026-03-24. Applicant: Aap Implantate AG. Device class: 2.
Summary
Aap Implantate's LOQTEQ® VA Proximal Humerus Plate 3.5 is filed under HRS, bone fixation plates. The record doesn't list plate lengths or hole counts.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Aap Implantate filed from Berlin, Germany. Review took 85 calendar days (December 29, 2025 to March 24, 2026).
Clearance details
- Applicant
- Aap Implantate AG
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berlin, DE
Recent devices under product code HRS
view allMore clearances from Aap Implantate AG
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.