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FDA 510(k)

IMPLEX SCREW AND WASHER SYSTEM

K-Number: K982751 · 1999-02-01

ApplicantImplex Corp.
Decision Date1999-02-01
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLEX SCREW AND WASHER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1999-02-01 under 510(k) number K982751. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLEX SCREW AND WASHER SYSTEM?

IMPLEX SCREW AND WASHER SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-01. The listed applicant is Implex Corp.. The 510(k) number is K982751.

When did IMPLEX SCREW AND WASHER SYSTEM receive FDA 510(k) clearance?

IMPLEX SCREW AND WASHER SYSTEM received FDA 510(k) clearance on 1999-02-01, under 510(k) number K982751.

Who is the listed applicant for IMPLEX SCREW AND WASHER SYSTEM?

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

What is the FDA product code for IMPLEX SCREW AND WASHER SYSTEM?

The FDA product code for IMPLEX SCREW AND WASHER SYSTEM is MBI.

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Other records listing Implex Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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