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FDA 510(k)

JOHNSON AND JOHNSON POWER SYSTEM

K-Number: K913629 · 1991-11-13

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1991-11-13
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JOHNSON AND JOHNSON POWER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. It received FDA 510(k) clearance on 1991-11-13 under 510(k) number K913629. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOHNSON AND JOHNSON POWER SYSTEM?

JOHNSON AND JOHNSON POWER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K913629.

When did JOHNSON AND JOHNSON POWER SYSTEM receive FDA 510(k) clearance?

JOHNSON AND JOHNSON POWER SYSTEM received FDA 510(k) clearance on 1991-11-13, under 510(k) number K913629.

Who is the listed applicant for JOHNSON AND JOHNSON POWER SYSTEM?

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

What is the FDA product code for JOHNSON AND JOHNSON POWER SYSTEM?

The FDA product code for JOHNSON AND JOHNSON POWER SYSTEM is HSZ.

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Other records listing Johnson & Johnson Orthopaedics, Inc. as applicant

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Related Devices (Code: HSZ)

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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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