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FDA 510(k)

Sonoma Fibula Repair System

K-Number: K160069 · 2016-03-10

ApplicantSonoma Orthopedics Products, Inc.
Decision Date2016-03-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sonoma Fibula Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Orthopedics Products, Inc.. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K160069. 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 Sonoma Fibula Repair System?

Sonoma Fibula Repair System is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Sonoma Orthopedics Products, Inc.. The 510(k) number is K160069.

When did Sonoma Fibula Repair System receive FDA 510(k) clearance?

Sonoma Fibula Repair System received FDA 510(k) clearance on 2016-03-10, under 510(k) number K160069.

Who is the listed applicant for Sonoma Fibula Repair System?

The FDA 510(k) record lists Sonoma Orthopedics Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonoma Fibula Repair System?

The FDA product code for Sonoma Fibula Repair System is HSB.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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