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FDA 510(k)

MectaLock PEEK Suture Anchor

K-Number: K190474 · 2019-05-28

ApplicantMedacta International S.A.
Decision Date2019-05-28
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLock PEEK Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2019-05-28 under 510(k) number K190474. 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 MectaLock PEEK Suture Anchor?

MectaLock PEEK Suture Anchor is a medical device that received FDA 510(k) clearance on 2019-05-28. The listed applicant is Medacta International S.A.. The 510(k) number is K190474.

When did MectaLock PEEK Suture Anchor receive FDA 510(k) clearance?

MectaLock PEEK Suture Anchor received FDA 510(k) clearance on 2019-05-28, under 510(k) number K190474.

Who is the listed applicant for MectaLock PEEK Suture Anchor?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MectaLock PEEK Suture Anchor?

The FDA product code for MectaLock PEEK Suture Anchor is MBI.

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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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