FDA 510(k)

TOTAL OSSICULAR REPLACEMENT

K-Number: K823919 · 1983-06-24

Decision Date1983-06-24

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

TOTAL OSSICULAR REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1983-06-24 under 510(k) number K823919. 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?

TOTAL OSSICULAR REPLACEMENT is a medical device that received FDA 510(k) clearance on 1983-06-24. The listed applicant is Treace Medical, Inc.. The 510(k) number is K823919.

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

TOTAL OSSICULAR REPLACEMENT received FDA 510(k) clearance on 1983-06-24, under 510(k) number K823919.

Who is the listed applicant for TOTAL OSSICULAR REPLACEMENT?

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

What is the FDA product code for TOTAL OSSICULAR REPLACEMENT?

The FDA product code for TOTAL OSSICULAR REPLACEMENT is ETA.

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Other records listing Treace Medical, Inc. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.