Prosthesis, Partial Ossicular Replacement
FDA product code ETB · 74 cleared devices
Class 2
Ear, Nose, Throat
- Regulation
- 21 CFR 874.3450
- Review panel
- EN
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-09-27 – 2026-04-03
ETB
2026-04-03
ETB
2026-04-03
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)
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ETB
2025-01-17
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
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ETB
2025-01-17
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
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ETB
2013-12-02
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
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ETB
2013-02-08
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
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ETB
2008-04-17
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
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ETB
2006-12-06
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
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ETB
2006-08-18
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
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ETB
2006-06-28
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
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ETB
2003-11-24
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
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ETB
2002-05-21
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
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ETB
2001-11-09
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
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ETB
2001-03-08
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
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ETB
2000-10-31
SMITH & NEPHEW PISTONS
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ETB
2000-10-12
SMITH & NEPHEW PORPS & TORPS
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ETB
2000-10-11
TITANIUM MIDDLE EAR PROSTHESES
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ETB
2000-08-29
SMITH & NEPHEW OFF-CENTERED PORP
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ETB
2000-08-09
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
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ETB
2000-06-23
AUDIO TECHNOLOGIES S:R.1
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ETB
2000-04-03
WEHRS INCUS-STAPES
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ETB
2000-02-11
CAP PORP, CAP TORP
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ETB
1999-11-10
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
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ETB
1999-09-16
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
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ETB
1999-05-18
STAPES PROSTHESES
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ETB
1999-03-31
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
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ETB
1998-05-20
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
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ETB
1998-01-22
MILLS INCUS HA SLEEVE
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ETB
1997-11-21
K-PISTON WITH BAND HOOK /ANGULAR PISTON
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ETB
1997-10-08
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
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ETB
1997-09-05
CAUSSE PISTON
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ETB
1997-09-05
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
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ETB
1997-08-04
BELL PROSTHESIS (PARTIAL)
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ETB
1997-03-10
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
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ETB
1997-01-22
RICHARDS TOTAL/PARTIAL PROSTHESIS
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ETB
1997-01-02
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
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ETB
1996-10-10
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
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ETB
1996-05-14
POLY/PLATINUM WIRE PISTON
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ETB
1995-12-22
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
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ETB
1995-10-27
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
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ETB
1995-06-16
RICHARDS PORP
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ETB
1995-03-15
HAPES MALLEABLE INCUS STAPES
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ETB
1995-03-15
HAPEX INCUS
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ETB
1995-03-15
HAPEX PORP
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ETB
1995-03-15
HAPEX MALLEABLE PORP
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ETB
1994-11-22
POLY PISTON
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ETB
1994-11-22
POLY-WIRE PISTON
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ETB
1994-11-22
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
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ETB
1993-03-08
INCUDOSTAPEDIAL JOINT
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ETB
1991-12-27
TEF/PLATINUM PISTON
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ETB
1991-12-23
TEF/WIRE PISTON
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ETB
1991-12-18
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
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ETB
1991-12-18
PTFE PISTON
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ETB
1991-12-04
WEHRS INCUS AND INCUS-STAPES PROSTHESES
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ETB
1991-10-15
CERAVITAL MIDDLE EAR IMPLANT
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ETB
1989-12-26
MICROTEK PISTON & WIRE PROSTHESES
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ETB
1989-08-03
APACERAM OSSICULAR PROSTHESIS
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ETB
1989-01-13
BUCKET PROSTHESIS PORP
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ETB
1987-07-02
XOMED PLATINUM WIRE TEFLON PISTION
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ETB
1987-04-15
PROSTHESIS WIRE
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ETB
1986-07-14
INCUS/STAPES PROSTHESIS
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ETB
1986-07-11
MICROTEK STAINLESS STEEL PISTON
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ETB
1985-02-26
INCUS PROSTHESIS
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ETB
1984-07-06
CAUSSE SPONGE BOAT
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ETB
1984-01-03
DRUMTO STAPES PROSTHESIS
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ETB
1982-12-09
STAINLESS STEEL PISTONS
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ETB
1982-12-03
MCGEE MODIFIED STAINLESS STEEL PISTON
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ETB
1982-12-03
CAUSSE TEF-PISTON
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ETB
1982-12-03
FISCH MODIFIED TEF-WIRE PISTON
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ETB
1980-12-19
SHEA LOCKING BAIL PROSTHESIS
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ETB
1980-11-12
SCHURING OSSICLE CUP & COLUMELLA PROSTH.
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ETB
1976-10-05
CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
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ETB
1976-10-05
TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY
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ETB
1976-09-27
PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
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