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FDA 510(k)

POLY BLADES

K-Number: K940515 · 1994-05-26

ApplicantLinvatec Corp.
Decision Date1994-05-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLY BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1994-05-26 under 510(k) number K940515. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY BLADES?

POLY BLADES is a medical device that received FDA 510(k) clearance on 1994-05-26. The listed applicant is Linvatec Corp.. The 510(k) number is K940515.

When did POLY BLADES receive FDA 510(k) clearance?

POLY BLADES received FDA 510(k) clearance on 1994-05-26, under 510(k) number K940515.

Who is the listed applicant for POLY BLADES?

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

What is the FDA product code for POLY BLADES?

The FDA product code for POLY BLADES is HRX.

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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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