DRACO Locking Bone Screws +4 more— 510(k) K163486

Name: FDA 510(k) clearance K163486
Creator: U.S. Food and Drug Administration
Published: 2017-07-24

Substantially Equivalent

Hnm Total Recon, LLC

FDA 510(k) clearance K163486 for DRACO Locking Bone Screws +4 more, Substantially Equivalent on 2017-07-24. Applicant: Hnm Total Recon, LLC. Device class: 2.

Clearance details

Device name as filed: DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates
Applicant: Hnm Total Recon, LLC
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2016-12-12
Decision date: 2017-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.