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FDA 510(k)

X-Twist Biocomposite Suture Anchor

K-Number: K232513 · 2023-09-18

ApplicantParcus Medical
Decision Date2023-09-18
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-Twist Biocomposite Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K232513. 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 X-Twist Biocomposite Suture Anchor?

X-Twist Biocomposite Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Parcus Medical. The 510(k) number is K232513.

When did X-Twist Biocomposite Suture Anchor receive FDA 510(k) clearance?

X-Twist Biocomposite Suture Anchor received FDA 510(k) clearance on 2023-09-18, under 510(k) number K232513.

Who is the listed applicant for X-Twist Biocomposite Suture Anchor?

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

What is the FDA product code for X-Twist Biocomposite Suture Anchor?

The FDA product code for X-Twist Biocomposite Suture Anchor is MAI.

Other records listing Parcus Medical 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.

K221502Parcus 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 HipK201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors

View all 18 devices →

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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