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FDA 510(k)

GENESIS CONSTRAINED SYSTEM (GCS)

K-Number: K952271 · 1995-09-08

ApplicantSmith & Nephew Richards, Inc.
Decision Date1995-09-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENESIS CONSTRAINED SYSTEM (GCS) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K952271. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS CONSTRAINED SYSTEM (GCS)?

GENESIS CONSTRAINED SYSTEM (GCS) is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K952271.

When did GENESIS CONSTRAINED SYSTEM (GCS) receive FDA 510(k) clearance?

GENESIS CONSTRAINED SYSTEM (GCS) received FDA 510(k) clearance on 1995-09-08, under 510(k) number K952271.

Who is the listed applicant for GENESIS CONSTRAINED SYSTEM (GCS)?

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

What is the FDA product code for GENESIS CONSTRAINED SYSTEM (GCS)?

The FDA product code for GENESIS CONSTRAINED SYSTEM (GCS) is JWH.

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Other records listing Smith & Nephew Richards, Inc. 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEM

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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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