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FDA 510(k)

TRIAXIAL

K-Number: K802348 · 1981-02-23

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1981-02-23
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIAXIAL is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1981-02-23 under 510(k) number K802348. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIAXIAL?

TRIAXIAL is a medical device that received FDA 510(k) clearance on 1981-02-23. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K802348.

When did TRIAXIAL receive FDA 510(k) clearance?

TRIAXIAL received FDA 510(k) clearance on 1981-02-23, under 510(k) number K802348.

Who is the listed applicant for TRIAXIAL?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIAXIAL?

The FDA product code for TRIAXIAL is JDB.

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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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