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FDA 510(k)

SUTUREFIX Curved Suture Anchor

K-Number: K163034 · 2016-12-07

ApplicantSmith and Nephew, Inc.
Decision Date2016-12-07
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTUREFIX Curved Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2016-12-07 under 510(k) number K163034. 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 SUTUREFIX Curved Suture Anchor?

SUTUREFIX Curved Suture Anchor is a medical device that received FDA 510(k) clearance on 2016-12-07. The listed applicant is Smith and Nephew, Inc.. The 510(k) number is K163034.

When did SUTUREFIX Curved Suture Anchor receive FDA 510(k) clearance?

SUTUREFIX Curved Suture Anchor received FDA 510(k) clearance on 2016-12-07, under 510(k) number K163034.

Who is the listed applicant for SUTUREFIX Curved Suture Anchor?

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

What is the FDA product code for SUTUREFIX Curved Suture Anchor?

The FDA product code for SUTUREFIX Curved Suture Anchor is MBI.

Other records listing Smith and Nephew, 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.

PMA P210034Implant, resorbable, for articular osteochondral repairK222501Regeneten Bioinductive ImplantK221740SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera HeadK183232Double ENDOBUTTON Fixation DeviceK181746MICRORAPTOR Knotless Suture Anchor

View all 8 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.

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.K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.

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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