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GRYPHON® Anchors with DYNACORD™ Suture

K181809 Class II Special
Decision Date
2018-08-03
Sponsor / Applicant
Medos International SARL

Technical Specification

510(k) Submission ID K181809
Product Code MAI
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3030
Decision Date 2018-08-03
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

GRYPHON® Anchors with DYNACORD™ Suture received FDA 510(k) clearance under submission number K181809, sponsored by Medos International SARL. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-08-03.

Classification & Regulation

This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.