Atlas FDA

NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE

FDA 510(k) clearance K063374 · decided 2006-12-06

Clearance details

K-number
K063374
Device name
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
Applicant
Grace Medical, Inc.
Decision
Substantially Equivalent
Date received
2006-11-08
Decision date
2006-12-06
Days to decision
28 days
Clearance type
Traditional
Product code
ETB
Device class
2
Regulation number
874.3450
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K260718)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (K260720)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (K241261)MED-EL Elektromedizinische Geräte GmbH2025-01-17
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (K241142)MED-EL Elektromedizinische Geräte GmbH2025-01-17
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS (K130512)Heinz Kurz GmbH Medizintechnik2013-12-02
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GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES (K061853)Grace Medical, Inc.2006-08-18
PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K060518)Grace Medical, Inc.2006-06-28
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (K033554)Gyrus Ent LLC2003-11-24
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (K021479)Heinz Kurz GmbH Medizintechnik2002-05-21
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 (K013573)Heinz Kurz GmbH Medizintechnik2001-11-09

Recalls involving this device

No recalls on record reference this clearance.