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FDA 510(k)

ALPHATEC SMALL FRAGMENT SET

K-Number: K922166 · 1992-08-06

ApplicantAlphatec Mfg., Inc.
Decision Date1992-08-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHATEC SMALL FRAGMENT SET 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 1992-08-06 under 510(k) number K922166. 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 SMALL FRAGMENT SET?

ALPHATEC SMALL FRAGMENT SET is a medical device that received FDA 510(k) clearance on 1992-08-06. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K922166.

When did ALPHATEC SMALL FRAGMENT SET receive FDA 510(k) clearance?

ALPHATEC SMALL FRAGMENT SET received FDA 510(k) clearance on 1992-08-06, under 510(k) number K922166.

Who is the listed applicant for ALPHATEC SMALL FRAGMENT SET?

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 SMALL FRAGMENT SET?

The FDA product code for ALPHATEC SMALL FRAGMENT SET 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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