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FDA 510(k)

Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors

K-Number: K201083 · 2020-07-23

ApplicantParcus Medical, LLC
Decision Date2020-07-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2020-07-23 under approval number K201083. 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 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors?

Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors is a medical device that received FDA 510(k) clearance on 2020-07-23. It is manufactured by Parcus Medical, LLC. The 510(k) number is K201083.

When was Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors approved by the FDA?

Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors received FDA 510(k) clearance on 2020-07-23, under approval number K201083.

What company makes Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors?

Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors is manufactured by Parcus Medical, LLC.

What is the FDA product code for Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors?

The FDA product code for Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

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 Parcus Medical, LLC

K162198GFS Ultimate K192964Parcus Synd-EZ SS K192824Parcus Knotless AP Suture Anchors K191783Parcus Synd-EZ Ti K190375Parcus ATLAS K183501Parcus Twist AP Suture Anchors

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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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