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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 the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-03-15 under 510(k) 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. The listed applicant is Parcus Medical, LLC. The 510(k) number is K183501.

When did Parcus Twist AP Suture Anchors receive FDA 510(k) clearance?

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

Who is the listed applicant for Parcus Twist AP Suture Anchors?

The FDA 510(k) record lists Parcus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Parcus Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232513X-Twist Biocomposite Suture AnchorK221502Parcus Synd-EZ SSK221135X-Twist PEEK Suture AnchorK212739ActiFlipK202662Parcus Titanium Interference ScrewsK202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip

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Related Devices (Code: MAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed 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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