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FDA 510(k)

Diamond Orthopedic Bone Fixation Screws and Pins

K-Number: K180932 · 2018-05-09

ApplicantDiamond Orthopedic, LLC
Decision Date2018-05-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Diamond Orthopedic Bone Fixation Screws and Pins is a medical device manufactured by Diamond Orthopedic, LLC. It received FDA 510(k) clearance on 2018-05-09 under approval number K180932. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diamond Orthopedic Bone Fixation Screws and Pins?

Diamond Orthopedic Bone Fixation Screws and Pins is a medical device that received FDA 510(k) clearance on 2018-05-09. It is manufactured by Diamond Orthopedic, LLC. The 510(k) number is K180932.

When was Diamond Orthopedic Bone Fixation Screws and Pins approved by the FDA?

Diamond Orthopedic Bone Fixation Screws and Pins received FDA 510(k) clearance on 2018-05-09, under approval number K180932.

What company makes Diamond Orthopedic Bone Fixation Screws and Pins?

Diamond Orthopedic Bone Fixation Screws and Pins is manufactured by Diamond Orthopedic, LLC.

What is the FDA product code for Diamond Orthopedic Bone Fixation Screws and Pins?

The FDA product code for Diamond Orthopedic Bone Fixation Screws and Pins is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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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