Atlas FDA

KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652

FDA 510(k) clearance K010442 · decided 2001-03-08

Clearance details

K-number
K010442
Device name
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
Applicant
Heinz Kurz
Decision
Substantially Equivalent
Date received
2001-02-14
Decision date
2001-03-08
Days to decision
22 days
Clearance type
Special
Product code
ETB
Device class
2
Regulation number
874.3450
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Amsterdam 1017ap, NL
Third-party review
No
Expedited review
No

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

RecordFirmDate
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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
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NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS (K130512)Heinz Kurz GmbH Medizintechnik2013-12-02
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NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE (K063374)Grace Medical, Inc.2006-12-06
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

Recalls involving this device

No recalls on record reference this clearance.