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FDA 510(k)

OsteoMed ExtremiFix Mid and Large Screw System

K-Number: K163303 · 2017-04-04

ApplicantOsteomed, LLC
Decision Date2017-04-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoMed ExtremiFix Mid and Large Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed, LLC. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K163303. 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 OsteoMed ExtremiFix Mid and Large Screw System?

OsteoMed ExtremiFix Mid and Large Screw System is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is Osteomed, LLC. The 510(k) number is K163303.

When did OsteoMed ExtremiFix Mid and Large Screw System receive FDA 510(k) clearance?

OsteoMed ExtremiFix Mid and Large Screw System received FDA 510(k) clearance on 2017-04-04, under 510(k) number K163303.

Who is the listed applicant for OsteoMed ExtremiFix Mid and Large Screw System?

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

What is the FDA product code for OsteoMed ExtremiFix Mid and Large Screw System?

The FDA product code for OsteoMed ExtremiFix Mid and Large Screw System is HWC. This falls under the Cardiovascular category.

Other records listing Osteomed, LLC as applicant

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Related Devices (Code: HWC)

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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