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FDA 510(k)

LEFORTE NEUROSYSTEM BONE SCREW

K-Number: K091686 · 2009-11-13

ApplicantJeil Medical Corporation
Decision Date2009-11-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEFORTE NEUROSYSTEM BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2009-11-13 under 510(k) number K091686. 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 LEFORTE NEUROSYSTEM BONE SCREW?

LEFORTE NEUROSYSTEM BONE SCREW is a medical device that received FDA 510(k) clearance on 2009-11-13. The listed applicant is Jeil Medical Corporation. The 510(k) number is K091686.

When did LEFORTE NEUROSYSTEM BONE SCREW receive FDA 510(k) clearance?

LEFORTE NEUROSYSTEM BONE SCREW received FDA 510(k) clearance on 2009-11-13, under 510(k) number K091686.

Who is the listed applicant for LEFORTE NEUROSYSTEM BONE SCREW?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEFORTE NEUROSYSTEM BONE SCREW?

The FDA product code for LEFORTE NEUROSYSTEM BONE SCREW is HWC. This falls under the Cardiovascular category.

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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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