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FDA 510(k)

MEDICINELODGE, INC. SET SCREW

K-Number: K961905 · 1996-08-06

ApplicantMedicinelodge, Inc.
Decision Date1996-08-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDICINELODGE, INC. SET 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 1996-08-06 under 510(k) number K961905. 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 MEDICINELODGE, INC. SET SCREW?

MEDICINELODGE, INC. SET SCREW is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Medicinelodge, Inc.. The 510(k) number is K961905.

When did MEDICINELODGE, INC. SET SCREW receive FDA 510(k) clearance?

MEDICINELODGE, INC. SET SCREW received FDA 510(k) clearance on 1996-08-06, under 510(k) number K961905.

Who is the listed applicant for MEDICINELODGE, INC. SET 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 MEDICINELODGE, INC. SET SCREW?

The FDA product code for MEDICINELODGE, INC. SET 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 PINK962194MLI SOFT TISSUE SCREW & WASHER SYSTEMK961025EXPANDED BODY SUTURE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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