FDA 510(k)

GRYPHON® Anchors with DYNACORD Suture

K-Number: K181809 · 2018-08-03

Decision Date2018-08-03

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GRYPHON® Anchors with DYNACORD Suture is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2018-08-03 under approval number K181809. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRYPHON® Anchors with DYNACORD Suture?

GRYPHON® Anchors with DYNACORD Suture is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Medos International SARL. The 510(k) number is K181809.

When was GRYPHON® Anchors with DYNACORD Suture approved by the FDA?

GRYPHON® Anchors with DYNACORD Suture received FDA 510(k) clearance on 2018-08-03, under approval number K181809.

What company makes GRYPHON® Anchors with DYNACORD Suture?

GRYPHON® Anchors with DYNACORD Suture is manufactured by Medos International SARL.

What is the FDA product code for GRYPHON® Anchors with DYNACORD Suture?

The FDA product code for GRYPHON® Anchors with DYNACORD Suture is MAI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Medos International SARL

K162247PERMATAPE K162327COUGAR® LS Lateral Cage System and COUGAR® System K162912VIPER PRIME additions to the VIPER® System K163106CODMAN Integrated Bipolar Cord and Tubing Set K161638SPEEDTRAP Graft Preparation System K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps

View all 73 devices →

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.