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FDA 510(k)

SHUTTLE STOP

K-Number: K000587 · 2000-05-04

ApplicantIsotis NV
Decision Date2000-05-04
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHUTTLE STOP is the device name listed in this FDA 510(k) record. The listed applicant is Isotis NV. It received FDA 510(k) clearance on 2000-05-04 under 510(k) number K000587. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHUTTLE STOP?

SHUTTLE STOP is a medical device that received FDA 510(k) clearance on 2000-05-04. The listed applicant is Isotis NV. The 510(k) number is K000587.

When did SHUTTLE STOP receive FDA 510(k) clearance?

SHUTTLE STOP received FDA 510(k) clearance on 2000-05-04, under 510(k) number K000587.

Who is the listed applicant for SHUTTLE STOP?

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

What is the FDA product code for SHUTTLE STOP?

The FDA product code for SHUTTLE STOP is LZN.

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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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