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FDA 510(k)

ALLthread PEEK Suture Anchor

K-Number: K193402 · 2020-03-05

ApplicantBiomet, Inc.
Decision Date2020-03-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALLthread PEEK Suture Anchor is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2020-03-05 under approval number K193402. 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 ALLthread PEEK Suture Anchor?

ALLthread PEEK Suture Anchor is a medical device that received FDA 510(k) clearance on 2020-03-05. It is manufactured by Biomet, Inc.. The 510(k) number is K193402.

When was ALLthread PEEK Suture Anchor approved by the FDA?

ALLthread PEEK Suture Anchor received FDA 510(k) clearance on 2020-03-05, under approval number K193402.

What company makes ALLthread PEEK Suture Anchor?

ALLthread PEEK Suture Anchor is manufactured by Biomet, Inc..

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

The FDA product code for ALLthread PEEK 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)

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. 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

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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