FDA 510(k)

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)

K-Number: K972735 · 1997-09-05

Decision Date1997-09-05

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) is the device name listed in this FDA 510(k) record. The listed applicant is Mednet Locator, Inc.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K972735. 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 TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)?

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Mednet Locator, Inc.. The 510(k) number is K972735.

When did TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) receive FDA 510(k) clearance?

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) received FDA 510(k) clearance on 1997-09-05, under 510(k) number K972735.

Who is the listed applicant for TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)?

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

What is the FDA product code for TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)?

The FDA product code for TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) is ETA.

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Other records listing Mednet Locator, Inc. as applicant

K001404GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON K001406HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES K974174ULTRABUR K972734PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)K972737CAUSSE PISTON K972126MYRINGOTOMY TUBE

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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.