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FDA 510(k)

Parcus Knotless AP Suture Anchors

K-Number: K192824 · 2019-11-02

ApplicantParcus Medical, LLC
Decision Date2019-11-02
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Parcus Knotless AP Suture Anchors is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-11-02 under approval number K192824. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Parcus Knotless AP Suture Anchors?

Parcus Knotless AP Suture Anchors is a medical device that received FDA 510(k) clearance on 2019-11-02. It is manufactured by Parcus Medical, LLC. The 510(k) number is K192824.

When was Parcus Knotless AP Suture Anchors approved by the FDA?

Parcus Knotless AP Suture Anchors received FDA 510(k) clearance on 2019-11-02, under approval number K192824.

What company makes Parcus Knotless AP Suture Anchors?

Parcus Knotless AP Suture Anchors is manufactured by Parcus Medical, LLC.

What is the FDA product code for Parcus Knotless AP Suture Anchors?

The FDA product code for Parcus Knotless AP Suture Anchors is MAI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_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 K191783Parcus Synd-EZ Ti K190375Parcus ATLAS K183501Parcus Twist AP Suture Anchors K183331Parcus GFS BTB

View all 15 devices →

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

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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