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FDA 510(k)

PARCUS PPEK CF INTERFERENCE SCREW

K-Number: K091093 · 2009-09-30

ApplicantParcus Medical, LLC
Decision Date2009-09-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARCUS PPEK CF INTERFERENCE SCREW 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 2009-09-30 under 510(k) number K091093. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARCUS PPEK CF INTERFERENCE SCREW?

PARCUS PPEK CF INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2009-09-30. The listed applicant is Parcus Medical, LLC. The 510(k) number is K091093.

When did PARCUS PPEK CF INTERFERENCE SCREW receive FDA 510(k) clearance?

PARCUS PPEK CF INTERFERENCE SCREW received FDA 510(k) clearance on 2009-09-30, under 510(k) number K091093.

Who is the listed applicant for PARCUS PPEK CF INTERFERENCE SCREW?

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 PPEK CF INTERFERENCE SCREW?

The FDA product code for PARCUS PPEK CF INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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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.

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

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Related Devices (Code: HWC)

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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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