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FDA 510(k)

LITe BIO Delivery System

K-Number: K160978 · 2016-07-08

ApplicantStryker Corporation
Decision Date2016-07-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LITe BIO Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K160978. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITe BIO Delivery System?

LITe BIO Delivery System is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Stryker Corporation. The 510(k) number is K160978.

When did LITe BIO Delivery System receive FDA 510(k) clearance?

LITe BIO Delivery System received FDA 510(k) clearance on 2016-07-08, under 510(k) number K160978.

Who is the listed applicant for LITe BIO Delivery System?

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

What is the FDA product code for LITe BIO Delivery System?

The FDA product code for LITe BIO Delivery System is FMF.

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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.

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