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FDA 510(k)

ALTA FULLY THREADED CROSS-LOCKING SCREWS

K-Number: K963398 · 1996-10-10

ApplicantHowmedica Corp.
Decision Date1996-10-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTA FULLY THREADED CROSS-LOCKING SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K963398. 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 ALTA FULLY THREADED CROSS-LOCKING SCREWS?

ALTA FULLY THREADED CROSS-LOCKING SCREWS is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is Howmedica Corp.. The 510(k) number is K963398.

When did ALTA FULLY THREADED CROSS-LOCKING SCREWS receive FDA 510(k) clearance?

ALTA FULLY THREADED CROSS-LOCKING SCREWS received FDA 510(k) clearance on 1996-10-10, under 510(k) number K963398.

Who is the listed applicant for ALTA FULLY THREADED CROSS-LOCKING SCREWS?

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 ALTA FULLY THREADED CROSS-LOCKING SCREWS?

The FDA product code for ALTA FULLY THREADED CROSS-LOCKING SCREWS is HWC. This falls under the Cardiovascular category.

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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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