FDA Product Code ETA: Replacement, Ossicular Prosthesis, Total

Cleared Jun 08, 1994

BLACK OVAL-TOP TORP/PORP

K934107

Smith & Nephew Richards, Inc.

Ear, Nose, Throat · 289d

Cleared Dec 18, 1991

H/A TOTAL-REGULAR, H/A TOTAL-OFFSET

K913286

River Medical, Inc.

Ear, Nose, Throat · 147d

Cleared Sep 09, 1991

IONOS(R) OSSICLE 5MM & 7MM

K911583

Ionos GmbH & Co. KG

Ear, Nose, Throat · 154d

Cleared Jun 21, 1991

SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES

K904239

Microbio-Medics, Inc.

Ear, Nose, Throat · 281d

Cleared Dec 26, 1989

MICROTEK TOTAL OSSICULAR PROTHESIS

K895815

Microbio-Medics, Inc.

Ear, Nose, Throat · 88d

Cleared Jun 16, 1989

OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL

K884884

Porex Technologies Corp. of Georgia

Ear, Nose, Throat · 206d

Cleared Apr 19, 1989

OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT

K885201

Microbio-Medics, Inc.

Ear, Nose, Throat · 124d

Cleared Feb 06, 1987

SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE

K864444

Richards Medical Co., Inc.

Ear, Nose, Throat · 86d

Cleared Feb 02, 1987

EGG-TOP TORP AND EGG-TOP PORP

K864443

Richards Medical Co., Inc.

Ear, Nose, Throat · 82d

Cleared Jan 09, 1985

BIOGLASS OSSICULAR RECONSTRUCTION PROSTH

K843461

American Biomaterials Corp.

Ear, Nose, Throat · 126d

Cleared Jun 24, 1983

AUSTIN MODIFIED TOTAL OSSICULAR REPLACE

K823912

Treace Medical, Inc.

Ear, Nose, Throat · 178d

Cleared Jun 24, 1983

PARTIAL OSSICULAR REPLACEMENT

K823917

Treace Medical, Inc.

Ear, Nose, Throat · 178d

Cleared Jun 24, 1983

AUSTIN MODIFIED PARTIAL OSSICULAR RE-

K823918

Treace Medical, Inc.

Ear, Nose, Throat · 178d

Cleared Jun 24, 1983

TOTAL OSSICULAR REPLACEMENT

K823919

Treace Medical, Inc.

Ear, Nose, Throat · 178d

Cleared Jun 16, 1981

CERAVITAL CERAMIC OSSICULAR REPL. PROS.

K810707

Xomed, Inc.

Ear, Nose, Throat · 92d

Cleared Oct 05, 1976

SHEA TORP, OTOLOGY IMPLANT

K760433

Richard'S Medical Equip., Inc.

Ear, Nose, Throat · 50d