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FDA 510(k)

Parcus Synd-EZ Ti

K-Number: K191783 · 2019-10-09

ApplicantParcus Medical, LLC
Decision Date2019-10-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Parcus Synd-EZ Ti is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K191783. 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 Parcus Synd-EZ Ti?

Parcus Synd-EZ Ti is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Parcus Medical, LLC. The 510(k) number is K191783.

When did Parcus Synd-EZ Ti receive FDA 510(k) clearance?

Parcus Synd-EZ Ti received FDA 510(k) clearance on 2019-10-09, under 510(k) number K191783.

Who is the listed applicant for Parcus Synd-EZ Ti?

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

What is the FDA product code for Parcus Synd-EZ Ti?

The FDA product code for Parcus Synd-EZ Ti is MBI.

Other records listing Parcus Medical, LLC 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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