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FDA 510(k)

SYNTHES MULTILOC HUMERAL NAILING SYSTEM

K-Number: K120807 · 2012-07-06

ApplicantSynthes USA Products, LLC
Decision Date2012-07-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES MULTILOC HUMERAL NAILING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2012-07-06 under 510(k) number K120807. 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 MULTILOC HUMERAL NAILING SYSTEM?

SYNTHES MULTILOC HUMERAL NAILING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-06. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K120807.

When did SYNTHES MULTILOC HUMERAL NAILING SYSTEM receive FDA 510(k) clearance?

SYNTHES MULTILOC HUMERAL NAILING SYSTEM received FDA 510(k) clearance on 2012-07-06, under 510(k) number K120807.

Who is the listed applicant for SYNTHES MULTILOC HUMERAL NAILING SYSTEM?

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

What is the FDA product code for SYNTHES MULTILOC HUMERAL NAILING SYSTEM?

The FDA product code for SYNTHES MULTILOC HUMERAL NAILING SYSTEM is HSB.

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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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