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FDA 510(k)

ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW

K-Number: K922322 · 1992-08-05

ApplicantAlphatec Mfg., Inc.
Decision Date1992-08-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Mfg., Inc.. It received FDA 510(k) clearance on 1992-08-05 under 510(k) number K922322. 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 ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW?

ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW is a medical device that received FDA 510(k) clearance on 1992-08-05. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K922322.

When did ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW receive FDA 510(k) clearance?

ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW received FDA 510(k) clearance on 1992-08-05, under 510(k) number K922322.

Who is the listed applicant for ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW?

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

What is the FDA product code for ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW?

The FDA product code for ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW 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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