FDA 510(k)

ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM

K-Number: K993583 · 1999-11-10

Decision Date1999-11-10

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1999-11-10 under 510(k) number K993583. 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 ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM?

ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-10. The listed applicant is Stryker Corp.. The 510(k) number is K993583.

When did ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM receive FDA 510(k) clearance?

ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM received FDA 510(k) clearance on 1999-11-10, under 510(k) number K993583.

Who is the listed applicant for ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM?

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

What is the FDA product code for ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM?

The FDA product code for ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM 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 Stryker Corp. as applicant

K230045HipCheck K191259Stryker CrossFlow Integrated Arthroscopy Pump K182359HipCheck K122113MEMORY METAL STAPLES, EASYCLIP K122053SHAPEMATCH CUTTING GUIDE K122284HOFFMANN 3

View all 119 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.