Healthium Medtech Limited - FDA 510(k) Cleared Devices
Recent clearances: CEPTRE® Knotted UHMWPE Suture PEEK Anchor, SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant, INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Healthium Medtech Limited Orthopedic ✕
5 devices
Cleared
Jan 04, 2024
CEPTRE® Knotted UHMWPE Suture PEEK Anchor
Orthopedic
268d
Cleared
Dec 28, 2023
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
Orthopedic
272d
Cleared
Nov 08, 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
Orthopedic
51d
Cleared
Aug 04, 2023
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button,...
Orthopedic
81d
Cleared
Mar 22, 2023
Stativ® Knotted UHMWPE Suture Anchor
Orthopedic
85d