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FDA 510(k)

Parcus Twist AP Suture Anchors

K-Number: K183501 · 2019-03-15

ApplicantParcus Medical, LLC
Decision Date2019-03-15
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Parcus Twist AP Suture Anchors is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-03-15 under approval number K183501. 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 Twist AP Suture Anchors?

Parcus Twist AP Suture Anchors is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Parcus Medical, LLC. The 510(k) number is K183501.

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

Parcus Twist AP Suture Anchors received FDA 510(k) clearance on 2019-03-15, under approval number K183501.

What company makes Parcus Twist AP Suture Anchors?

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

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

The FDA product code for Parcus Twist 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

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 K183331Parcus GFS BTB

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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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