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FDA 510(k)

LAG SCREW

K-Number: K903244 · 1990-07-30

ApplicantOnyx Medical Corp.
Decision Date1990-07-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAG SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Onyx Medical Corp.. It received FDA 510(k) clearance on 1990-07-30 under 510(k) number K903244. 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 LAG SCREW?

LAG SCREW is a medical device that received FDA 510(k) clearance on 1990-07-30. The listed applicant is Onyx Medical Corp.. The 510(k) number is K903244.

When did LAG SCREW receive FDA 510(k) clearance?

LAG SCREW received FDA 510(k) clearance on 1990-07-30, under 510(k) number K903244.

Who is the listed applicant for LAG SCREW?

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

What is the FDA product code for LAG SCREW?

The FDA product code for LAG SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Onyx Medical Corp. as applicant

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.

K942022FACE-IT SHIELDK931690SPOON PLATEK934614MINI FRAGMENT PLATEK931692T-PLATEK931680CANNULATED CANCELLOUS SCREWK931684EPIPHYSIS PLATE

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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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