FDA 510(k)

FIXATION SYSTEM

K-Number: K983318 · 1999-03-01

Decision Date1999-03-01

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Surgical Innovations. It received FDA 510(k) clearance on 1999-03-01 under 510(k) number K983318. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXATION SYSTEM?

FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-03-01. The listed applicant is General Surgical Innovations. The 510(k) number is K983318.

When did FIXATION SYSTEM receive FDA 510(k) clearance?

FIXATION SYSTEM received FDA 510(k) clearance on 1999-03-01, under 510(k) number K983318.

Who is the listed applicant for FIXATION SYSTEM?

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

What is the FDA product code for FIXATION SYSTEM?

The FDA product code for FIXATION SYSTEM is GDW.

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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.