FDA 510(k)

BIOSPONGE RECONSTRUCTION DISCS

K-Number: K771727 · 1977-09-26

Decision Date1977-09-26

Product CodeJOF

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BIOSPONGE RECONSTRUCTION DISCS 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 K771727. The device is classified under product code JOF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSPONGE RECONSTRUCTION DISCS?

BIOSPONGE RECONSTRUCTION DISCS 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 K771727.

When did BIOSPONGE RECONSTRUCTION DISCS receive FDA 510(k) clearance?

BIOSPONGE RECONSTRUCTION DISCS received FDA 510(k) clearance on 1977-09-26, under 510(k) number K771727.

Who is the listed applicant for BIOSPONGE RECONSTRUCTION DISCS?

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 BIOSPONGE RECONSTRUCTION DISCS?

The FDA product code for BIOSPONGE RECONSTRUCTION DISCS is JOF.

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Other records listing Xomed, Inc. as applicant

K002395MODEL 30 CLASSIC PNEUMATONOMETER K002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE K002828XPS NITRO SYSTEM K002897TITANIUM MIDDLE EAR PROSTHESES K993653MICRO-FRANCE TROCARS AND ACCESSORIES K001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: JOF)

K200532StarPoreAnatomics Pty, Ltd.K171037PoreStar Patient Specific ImplantAnatomics Pty, Ltd.K083621MEDPOR CUSTOMIZED SURGICAL IMPLANTPorex Surgical, Inc.K002629SILMAX CONTOUR CARVING BLOCK IMPLANTPillar Surgical, Inc.K771726BIOSPONGE STAPES PISTONXomed, Inc.

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.