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FDA 510(k)

MLI INTERFERENCE SCREW

K-Number: K953350 · 1996-01-30

ApplicantMedicinelodge, Inc.
Decision Date1996-01-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MLI INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Medicinelodge, Inc.. It received FDA 510(k) clearance on 1996-01-30 under 510(k) number K953350. 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 for Some Indications.

Frequently Asked Questions

What is the MLI INTERFERENCE SCREW?

MLI INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 1996-01-30. The listed applicant is Medicinelodge, Inc.. The 510(k) number is K953350.

When did MLI INTERFERENCE SCREW receive FDA 510(k) clearance?

MLI INTERFERENCE SCREW received FDA 510(k) clearance on 1996-01-30, under 510(k) number K953350.

Who is the listed applicant for MLI INTERFERENCE SCREW?

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

What is the FDA product code for MLI INTERFERENCE SCREW?

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

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Other records listing Medicinelodge, Inc. 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.

K072525ZIPKNOT, MODEL 1017-3000K051488MEDICINELODGE ZIPKNOTK962705MLI MODULAR STAPLEK961920CROSS PINK961905MEDICINELODGE, INC. SET SCREWK962194MLI SOFT TISSUE SCREW & WASHER SYSTEM

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Related Devices (Code: HWC)

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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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