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FDA 510(k)

MLI SOFT TISSUE SCREW & WASHER SYSTEM

K-Number: K962194 · 1996-07-30

ApplicantMedicinelodge, Inc.
Decision Date1996-07-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MLI SOFT TISSUE SCREW & WASHER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicinelodge, Inc.. It received FDA 510(k) clearance on 1996-07-30 under 510(k) number K962194. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MLI SOFT TISSUE SCREW & WASHER SYSTEM?

MLI SOFT TISSUE SCREW & WASHER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-30. The listed applicant is Medicinelodge, Inc.. The 510(k) number is K962194.

When did MLI SOFT TISSUE SCREW & WASHER SYSTEM receive FDA 510(k) clearance?

MLI SOFT TISSUE SCREW & WASHER SYSTEM received FDA 510(k) clearance on 1996-07-30, under 510(k) number K962194.

Who is the listed applicant for MLI SOFT TISSUE SCREW & WASHER SYSTEM?

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 SOFT TISSUE SCREW & WASHER SYSTEM?

The FDA product code for MLI SOFT TISSUE SCREW & WASHER SYSTEM is MBI.

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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 SCREWK961025EXPANDED BODY SUTURE

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Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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