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FDA 510(k)

Tigon Medical Tissue Anchors

K-Number: K182507 · 2019-01-21

ApplicantTigon Medical
Decision Date2019-01-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical Tissue Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Tigon Medical. It received FDA 510(k) clearance on 2019-01-21 under 510(k) number K182507. 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 Tigon Medical Tissue Anchors?

Tigon Medical Tissue Anchors is a medical device that received FDA 510(k) clearance on 2019-01-21. The listed applicant is Tigon Medical. The 510(k) number is K182507.

When did Tigon Medical Tissue Anchors receive FDA 510(k) clearance?

Tigon Medical Tissue Anchors received FDA 510(k) clearance on 2019-01-21, under 510(k) number K182507.

Who is the listed applicant for Tigon Medical Tissue Anchors?

The FDA 510(k) record lists Tigon Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tigon Medical Tissue Anchors?

The FDA product code for Tigon Medical Tissue Anchors is MBI.

Other records listing Tigon Medical 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.

K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineK252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsK242529Tigon Medical All-Suture Anchors (ASA)K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)K220464Tigon Medical Gryphon Anchor LineK211049Tigon Medical Button System

View all 7 devices →

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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