FDA 510(k)

CERAVITAL CERAMIC OSSICULAR REPL. PROS.

K-Number: K810707 · 1981-06-16

Decision Date1981-06-16

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

CERAVITAL CERAMIC OSSICULAR REPL. PROS. is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1981-06-16 under 510(k) number K810707. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAVITAL CERAMIC OSSICULAR REPL. PROS.?

CERAVITAL CERAMIC OSSICULAR REPL. PROS. is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Xomed, Inc.. The 510(k) number is K810707.

When did CERAVITAL CERAMIC OSSICULAR REPL. PROS. receive FDA 510(k) clearance?

CERAVITAL CERAMIC OSSICULAR REPL. PROS. received FDA 510(k) clearance on 1981-06-16, under 510(k) number K810707.

Who is the listed applicant for CERAVITAL CERAMIC OSSICULAR REPL. PROS.?

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 CERAVITAL CERAMIC OSSICULAR REPL. PROS.?

The FDA product code for CERAVITAL CERAMIC OSSICULAR REPL. PROS. is ETA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 82 devices →

Related Devices (Code: ETA)

K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50MED-EL Elektromedizinische Geräte GmbH K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH K091187GRACE DYNAMIC TORPGrace Medical, Inc.K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2Audio Technologies S.R.L.K043375FISCH TITANIUM MIDDLE EAR PROSTHESESKarl Storz Endoscopy K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik

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.