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FDA 510(k)

TenoTac Soft Tissue Fixation System

K-Number: K203385 · 2021-02-11

ApplicantParagon 28, Inc.
Decision Date2021-02-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TenoTac Soft Tissue Fixation 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 2021-02-11 under 510(k) number K203385. 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 TenoTac Soft Tissue Fixation System?

TenoTac Soft Tissue Fixation System is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Paragon 28, Inc.. The 510(k) number is K203385.

When did TenoTac Soft Tissue Fixation System receive FDA 510(k) clearance?

TenoTac Soft Tissue Fixation System received FDA 510(k) clearance on 2021-02-11, under 510(k) number K203385.

Who is the listed applicant for TenoTac Soft Tissue Fixation 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 TenoTac Soft Tissue Fixation System?

The FDA product code for TenoTac Soft Tissue Fixation System is MBI.

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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.

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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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