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FDA 510(k)

SCREWLINE

K-Number: K022425 · 2002-08-14

ApplicantAltatec Biotechnologies N.A., Inc.
Decision Date2002-08-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCREWLINE is the device name listed in this FDA 510(k) record. The listed applicant is Altatec Biotechnologies N.A., Inc.. It received FDA 510(k) clearance on 2002-08-14 under 510(k) number K022425. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCREWLINE?

SCREWLINE is a medical device that received FDA 510(k) clearance on 2002-08-14. The listed applicant is Altatec Biotechnologies N.A., Inc.. The 510(k) number is K022425.

When did SCREWLINE receive FDA 510(k) clearance?

SCREWLINE received FDA 510(k) clearance on 2002-08-14, under 510(k) number K022425.

Who is the listed applicant for SCREWLINE?

The FDA 510(k) record lists Altatec Biotechnologies N.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCREWLINE?

The FDA product code for SCREWLINE is DZE.

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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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