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FDA 510(k)

DARWIN KNEE SYSTEM

K-Number: K943462 · 1994-12-21

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1994-12-21
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DARWIN KNEE SYSTEM 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 1994-12-21 under 510(k) number K943462. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DARWIN KNEE SYSTEM?

DARWIN KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K943462.

When did DARWIN KNEE SYSTEM receive FDA 510(k) clearance?

DARWIN KNEE SYSTEM received FDA 510(k) clearance on 1994-12-21, under 510(k) number K943462.

Who is the listed applicant for DARWIN KNEE SYSTEM?

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 DARWIN KNEE SYSTEM?

The FDA product code for DARWIN KNEE SYSTEM is JWH.

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Related Devices (Code: JWH)

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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