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FDA 510(k)

BIOSPONGE STAPES PISTON

K-Number: K771726 · 1977-09-26

ApplicantXomed, Inc.
Decision Date1977-09-26
Product CodeJOF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIOSPONGE STAPES PISTON 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 K771726. 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 STAPES PISTON?

BIOSPONGE STAPES PISTON 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 K771726.

When did BIOSPONGE STAPES PISTON receive FDA 510(k) clearance?

BIOSPONGE STAPES PISTON received FDA 510(k) clearance on 1977-09-26, under 510(k) number K771726.

Who is the listed applicant for BIOSPONGE STAPES PISTON?

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 STAPES PISTON?

The FDA product code for BIOSPONGE STAPES PISTON is JOF.

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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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: JOF)

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.

K200532StarPoreAnatomics Pty, Ltd.K171037PoreStar Patient Specific ImplantAnatomics Pty, Ltd.K083621MEDPOR CUSTOMIZED SURGICAL IMPLANTPorex Surgical, Inc.K002629SILMAX CONTOUR CARVING BLOCK IMPLANTPillar Surgical, Inc.K771727BIOSPONGE RECONSTRUCTION DISCSXomed, 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.

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