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FDA 510(k)

EMBRACE THERMOPLASTIC

K-Number: K120335 · 2012-05-03

ApplicantBionix Development Corp.
Decision Date2012-05-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMBRACE THERMOPLASTIC is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K120335. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBRACE THERMOPLASTIC?

EMBRACE THERMOPLASTIC is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is Bionix Development Corp.. The 510(k) number is K120335.

When did EMBRACE THERMOPLASTIC receive FDA 510(k) clearance?

EMBRACE THERMOPLASTIC received FDA 510(k) clearance on 2012-05-03, under 510(k) number K120335.

Who is the listed applicant for EMBRACE THERMOPLASTIC?

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

What is the FDA product code for EMBRACE THERMOPLASTIC?

The FDA product code for EMBRACE THERMOPLASTIC is IYE.

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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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