Cleared Traditional

K220464 - Tigon Medical Gryphon Anchor Line (FDA 510(k) Clearance)

K220464 · Tigon Medical · Orthopedic device

Mar 2023

Decision

398d

Days

Class 2

Risk

K220464 is an FDA 510(k) clearance for the Tigon Medical Gryphon Anchor Line. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).

Submitted by Tigon Medical (Millersville, US). The FDA issued a Cleared decision on March 22, 2023, 398 days after receiving the submission on February 17, 2022.

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

Submission Details

510(k) Number	K220464 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 17, 2022
Decision Date	March 22, 2023
Days to Decision	398 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF