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FDA 510(k)

TWIST-OFF (TM) SCREW

K-Number: K971069 · 1997-07-09

ApplicantLandos, Inc.
Decision Date1997-07-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TWIST-OFF (TM) SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Landos, Inc.. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K971069. 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 TWIST-OFF (TM) SCREW?

TWIST-OFF (TM) SCREW is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Landos, Inc.. The 510(k) number is K971069.

When did TWIST-OFF (TM) SCREW receive FDA 510(k) clearance?

TWIST-OFF (TM) SCREW received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971069.

Who is the listed applicant for TWIST-OFF (TM) SCREW?

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

What is the FDA product code for TWIST-OFF (TM) SCREW?

The FDA product code for TWIST-OFF (TM) SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Landos, 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.

K964226MEMORY STAPLE (20 SIZES AVAILABLE)K97106834MM SCARF THREAD-HEAD(TM) SCREWK971070SCARF THREAD-HEAD (TM) HEAD SCREWK961732KARK97084622.2/+4MM CO CR & ZIRCONIA FEMORAL HEADK953111CORAIL

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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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