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FDA 510(k)

AMSEN SPINE IMPACTOR INSTRUMENTS

K-Number: K921645 · 1992-06-03

ApplicantAdvanced Med/Surg, Inc.
Decision Date1992-06-03
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMSEN SPINE IMPACTOR INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Med/Surg, Inc.. It received FDA 510(k) clearance on 1992-06-03 under 510(k) number K921645. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSEN SPINE IMPACTOR INSTRUMENTS?

AMSEN SPINE IMPACTOR INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1992-06-03. The listed applicant is Advanced Med/Surg, Inc.. The 510(k) number is K921645.

When did AMSEN SPINE IMPACTOR INSTRUMENTS receive FDA 510(k) clearance?

AMSEN SPINE IMPACTOR INSTRUMENTS received FDA 510(k) clearance on 1992-06-03, under 510(k) number K921645.

Who is the listed applicant for AMSEN SPINE IMPACTOR INSTRUMENTS?

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

What is the FDA product code for AMSEN SPINE IMPACTOR INSTRUMENTS?

The FDA product code for AMSEN SPINE IMPACTOR INSTRUMENTS is LXH.

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Other records listing Advanced Med/Surg, Inc. as applicant

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Related Devices (Code: LXH)

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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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