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FDA 510(k)

TRIMAX NAIL SYSTEM

K-Number: K964163 · 1996-12-27

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-12-27
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIMAX NAIL SYSTEM 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 1996-12-27 under 510(k) number K964163. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMAX NAIL SYSTEM?

TRIMAX NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-27. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K964163.

When did TRIMAX NAIL SYSTEM receive FDA 510(k) clearance?

TRIMAX NAIL SYSTEM received FDA 510(k) clearance on 1996-12-27, under 510(k) number K964163.

Who is the listed applicant for TRIMAX NAIL SYSTEM?

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 TRIMAX NAIL SYSTEM?

The FDA product code for TRIMAX NAIL SYSTEM is HSB.

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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 CONNECTORK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEMK962541REFLECTION ACETABULAR REINFORCEMENT RINGS

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Related Devices (Code: HSB)

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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