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FDA 510(k)

HEALIX ADVANCE PEEK ANCHOR

K-Number: K120449 · 2012-05-11

ApplicantDepuy Mitek
Decision Date2012-05-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE PEEK ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2012-05-11 under 510(k) number K120449. 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 HEALIX ADVANCE PEEK ANCHOR?

HEALIX ADVANCE PEEK ANCHOR is a medical device that received FDA 510(k) clearance on 2012-05-11. The listed applicant is Depuy Mitek. The 510(k) number is K120449.

When did HEALIX ADVANCE PEEK ANCHOR receive FDA 510(k) clearance?

HEALIX ADVANCE PEEK ANCHOR received FDA 510(k) clearance on 2012-05-11, under 510(k) number K120449.

Who is the listed applicant for HEALIX ADVANCE PEEK ANCHOR?

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

What is the FDA product code for HEALIX ADVANCE PEEK ANCHOR?

The FDA product code for HEALIX ADVANCE PEEK ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing Depuy Mitek 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.

K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorK241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsK240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewK080918DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0K060664FASTIN RC ANCHORK043298BLUE ORTHOCORD SUTURE

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Related Devices (Code: HWC)

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.

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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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