FDA 510(k)

SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)

K-Number: K100112 · 2010-09-28

ApplicantSonoma Orthopedic Products, Inc.

Decision Date2010-09-28

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Orthopedic Products, Inc.. It received FDA 510(k) clearance on 2010-09-28 under 510(k) number K100112. 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 SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)?

SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) is a medical device that received FDA 510(k) clearance on 2010-09-28. The listed applicant is Sonoma Orthopedic Products, Inc.. The 510(k) number is K100112.

When did SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) receive FDA 510(k) clearance?

SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) received FDA 510(k) clearance on 2010-09-28, under 510(k) number K100112.

Who is the listed applicant for SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)?

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

What is the FDA product code for SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)?

The FDA product code for SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) is HSB.

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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.