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FDA 510(k)

HEALIX ADVANCE SP PEEK Anchor

K-Number: K182941 · 2019-02-26

ApplicantMedos International SARL
Decision Date2019-02-26
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE SP PEEK Anchor is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2019-02-26 under approval number K182941. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALIX ADVANCE SP PEEK Anchor?

HEALIX ADVANCE SP PEEK Anchor is a medical device that received FDA 510(k) clearance on 2019-02-26. It is manufactured by Medos International SARL. The 510(k) number is K182941.

When was HEALIX ADVANCE SP PEEK Anchor approved by the FDA?

HEALIX ADVANCE SP PEEK Anchor received FDA 510(k) clearance on 2019-02-26, under approval number K182941.

What company makes HEALIX ADVANCE SP PEEK Anchor?

HEALIX ADVANCE SP PEEK Anchor is manufactured by Medos International SARL.

What is the FDA product code for HEALIX ADVANCE SP PEEK Anchor?

The FDA product code for HEALIX ADVANCE SP PEEK Anchor is MBI.

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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