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FDA 510(k)

MLI MODULAR STAPLE

K-Number: K962705 · 1996-10-01

ApplicantMedicinelodge, Inc.
Decision Date1996-10-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MLI MODULAR STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is Medicinelodge, Inc.. It received FDA 510(k) clearance on 1996-10-01 under 510(k) number K962705. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MLI MODULAR STAPLE?

MLI MODULAR STAPLE is a medical device that received FDA 510(k) clearance on 1996-10-01. The listed applicant is Medicinelodge, Inc.. The 510(k) number is K962705.

When did MLI MODULAR STAPLE receive FDA 510(k) clearance?

MLI MODULAR STAPLE received FDA 510(k) clearance on 1996-10-01, under 510(k) number K962705.

Who is the listed applicant for MLI MODULAR STAPLE?

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 MODULAR STAPLE?

The FDA product code for MLI MODULAR STAPLE is JDR.

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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 ZIPKNOTK961920CROSS PINK961905MEDICINELODGE, INC. SET SCREWK962194MLI SOFT TISSUE SCREW & WASHER SYSTEMK961025EXPANDED BODY SUTURE

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Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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