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FDA 510(k)

SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM

K-Number: K040336 · 2004-04-12

ApplicantSynthes (Usa)
Decision Date2004-04-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2004-04-12 under 510(k) number K040336. 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 SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM?

SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-12. The listed applicant is Synthes (Usa). The 510(k) number is K040336.

When did SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM receive FDA 510(k) clearance?

SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM received FDA 510(k) clearance on 2004-04-12, under 510(k) number K040336.

Who is the listed applicant for SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM?

The FDA product code for SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM is HSB.

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Other records listing Synthes (Usa) as applicant

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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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