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FDA 510(k)

Aevumed RAPID Suture Anchors

K-Number: K223878 · 2023-03-17

ApplicantAevumed, Inc.
Decision Date2023-03-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aevumed RAPID Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Aevumed, Inc.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K223878. 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 Aevumed RAPID Suture Anchors?

Aevumed RAPID Suture Anchors is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Aevumed, Inc.. The 510(k) number is K223878.

When did Aevumed RAPID Suture Anchors receive FDA 510(k) clearance?

Aevumed RAPID Suture Anchors received FDA 510(k) clearance on 2023-03-17, under 510(k) number K223878.

Who is the listed applicant for Aevumed RAPID Suture Anchors?

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

What is the FDA product code for Aevumed RAPID Suture Anchors?

The FDA product code for Aevumed RAPID Suture Anchors is MBI.

Other records listing Aevumed, 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.

K254306Aevumed FENIX Suture AnchorK260004Aevumed PROTEKT Suture AnchorK253040Aevumed FASE Suture AnchorK242895Aevumed PHANTOM Suture AnchorsK222363Aevumed PHANTOM™-LP Suture AnchorsK180464AEVUMED PHANTOM Suture Anchors

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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