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FDA 510(k)

Grappler Suture Anchor R3FLEX IOL System

K-Number: K240594 · 2024-03-26

ApplicantParagon 28, Inc.
Decision Date2024-03-26
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Grappler Suture Anchor R3FLEX IOL System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2024-03-26 under 510(k) number K240594. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Grappler Suture Anchor R3FLEX IOL System?

Grappler Suture Anchor R3FLEX IOL System is a medical device that received FDA 510(k) clearance on 2024-03-26. The listed applicant is Paragon 28, Inc.. The 510(k) number is K240594.

When did Grappler Suture Anchor R3FLEX IOL System receive FDA 510(k) clearance?

Grappler Suture Anchor R3FLEX IOL System received FDA 510(k) clearance on 2024-03-26, under 510(k) number K240594.

Who is the listed applicant for Grappler Suture Anchor R3FLEX IOL System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Grappler Suture Anchor R3FLEX IOL System?

The FDA product code for Grappler Suture Anchor R3FLEX IOL System is MBI.

Other records listing Paragon 28, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemK262047Grappler Suture Anchor SystemK253886Grappler Suture Anchor PCFD Tether SystemK253591Phantom® Hindfoot TTC/TC Nail SystemK253613Monkey Rings External Ring Fixation SystemK252106External Fixation Mini Rail System

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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.

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