Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2016-12-07 under approval 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. It is manufactured by Smith and Nephew, Inc.. The 510(k) number is K163034.

When was SUTUREFIX Curved Suture Anchor approved by the FDA?

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

What company makes SUTUREFIX Curved Suture Anchor?

SUTUREFIX Curved Suture Anchor is manufactured by Smith and Nephew, Inc..

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

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

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Smith and Nephew, Inc.

K181746MICRORAPTOR Knotless Suture Anchor K180361MICRORAPTOR REGENESORB Suture Anchor K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head K183232Double ENDOBUTTON Fixation Device K221740SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) K222501Regeneten Bioinductive Implant

View all 8 devices →

Related Devices (Code: MBI)

K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL K160655OrthoButton CLRiverpoint Medical

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.

↑