LYNC intramedullary implant— 510(k) K143049

Name: FDA 510(k) clearance K143049
Creator: U.S. Food and Drug Administration
Published: 2015-02-19

Substantially Equivalent

Novastep

FDA 510(k) clearance K143049 for LYNC intramedullary implant, Substantially Equivalent on 2015-02-19. Applicant: Novastep. Device class: 2.

Clearance details

Applicant: Novastep
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2014-10-23
Decision date: 2015-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Gregoire, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTY

view all

K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K253325 — ZipToe Hammertoe Fusion System2025-12-29
K252657 — Impact PEEK Union Nail System2025-09-19
K250315 — RONAVIS FX (FX-001)2025-08-01
K251362 — PediFlex Flexible Nail System2025-06-24

More clearances from Novastep

view all

K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples2023-12-04
K223468 — Nexis® compressive screws2023-08-30
K192356 — Airlock Centrolock Osteosynthesis Implant System2019-12-14
K151277 — Airlock® osteosynthesis plate system2015-08-13
K143523 — Airlock osteosynthesis plate system2015-04-06

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.