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FDA 510(k)

MILAGRO ADVANCE PEEK Interference Screw

K-Number: K161001 · 2016-06-09

Decision Date2016-06-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MILAGRO ADVANCE PEEK Interference Screw is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2016-06-09 under approval number K161001. 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 MILAGRO ADVANCE PEEK Interference Screw?

MILAGRO ADVANCE PEEK Interference Screw is a medical device that received FDA 510(k) clearance on 2016-06-09. It is manufactured by Medos International SARL. The 510(k) number is K161001.

When was MILAGRO ADVANCE PEEK Interference Screw approved by the FDA?

MILAGRO ADVANCE PEEK Interference Screw received FDA 510(k) clearance on 2016-06-09, under approval number K161001.

What company makes MILAGRO ADVANCE PEEK Interference Screw?

MILAGRO ADVANCE PEEK Interference Screw is manufactured by Medos International SARL.

What is the FDA product code for MILAGRO ADVANCE PEEK Interference Screw?

The FDA product code for MILAGRO ADVANCE PEEK Interference Screw is MBI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.