Cleared Traditional

K223889 - Stativ® Knotted UHMWPE Suture Anchor (FDA 510(k) Clearance)

K223889 · Healthium Medtech Limited · Orthopedic device

Mar 2023

Decision

85d

Days

Class 2

Risk

K223889 is an FDA 510(k) clearance for the Stativ® Knotted UHMWPE Suture Anchor. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).

Submitted by Healthium Medtech Limited (Bangalore, IN). The FDA issued a Cleared decision on March 22, 2023, 85 days after receiving the submission on December 27, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K223889 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 27, 2022
Decision Date	March 22, 2023
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF