Atlas FDA

GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

FDA 510(k) clearance K001404 · decided 2000-08-08

Clearance details

K-number
K001404
Device name
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
Applicant
Mednet Locator, Inc.
Decision
Substantially Equivalent
Date received
2000-05-03
Decision date
2000-08-08
Days to decision
97 days
Clearance type
Traditional
Product code
ETA
Device class
2
Regulation number
874.3495
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 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 (6.50 (K260719)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (K241269)MED-EL Elektromedizinische Geräte GmbH2025-01-17
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SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 (K083780)Audio Technologies S.R.L.2009-03-23
FISCH TITANIUM MIDDLE EAR PROSTHESES (K043375)Karl Storz Endoscopy2005-01-24
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (K042503)Heinz Kurz GmbH Medizintechnik2004-10-01
TITANIUM OSSICULAR REPLACMENT SYSTEM (K030492)Invotec International, Inc.2003-03-03
MODULAR PORP AND TORP MODEL TBD (K002378)Gyrus Ent LLC2000-08-29
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (K001406)Mednet Locator, Inc.2000-08-08
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (K001902)Gyrus Ent LLC2000-07-10
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM (K993583)Stryker Corp.1999-11-10
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES (K992138)Micromedics, Inc.1999-08-09

Recalls involving this device

No recalls on record reference this clearance.