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FDA 510(k)

3.5MM UNIVERSAL COMPRESSION SCREW

K-Number: K923477 · 1993-03-19

ApplicantHowmedica Corp.
Decision Date1993-03-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3.5MM UNIVERSAL COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1993-03-19 under 510(k) number K923477. 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 3.5MM UNIVERSAL COMPRESSION SCREW?

3.5MM UNIVERSAL COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 1993-03-19. The listed applicant is Howmedica Corp.. The 510(k) number is K923477.

When did 3.5MM UNIVERSAL COMPRESSION SCREW receive FDA 510(k) clearance?

3.5MM UNIVERSAL COMPRESSION SCREW received FDA 510(k) clearance on 1993-03-19, under 510(k) number K923477.

Who is the listed applicant for 3.5MM UNIVERSAL COMPRESSION SCREW?

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

What is the FDA product code for 3.5MM UNIVERSAL COMPRESSION SCREW?

The FDA product code for 3.5MM UNIVERSAL COMPRESSION SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Howmedica Corp. as applicant

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K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: HWC)

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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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