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FDA 510(k)

BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.

K-Number: K771725 · 1977-09-26

ApplicantXomed, Inc.
Decision Date1977-09-26
Product CodeFEX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1977-09-26 under 510(k) number K771725. The device is classified under product code FEX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.?

BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. is a medical device that received FDA 510(k) clearance on 1977-09-26. The listed applicant is Xomed, Inc.. The 510(k) number is K771725.

When did BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. receive FDA 510(k) clearance?

BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. received FDA 510(k) clearance on 1977-09-26, under 510(k) number K771725.

Who is the listed applicant for BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.?

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

What is the FDA product code for BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.?

The FDA product code for BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. is FEX.

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Other records listing Xomed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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