Atlas FDA

ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM

FDA 510(k) clearance K993583 · decided 1999-11-10

Clearance details

K-number
K993583
Device name
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
Applicant
Stryker Corp.
Decision
Substantially Equivalent
Date received
1999-10-22
Decision date
1999-11-10
Days to decision
19 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
Kalamazoo, MI, US
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
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
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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
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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
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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.

PMA approvals by this applicant

RecordFirmDate
VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033)Stryker Corp.2017-03-02
VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032)Stryker Corp.2015-07-16
VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031)Stryker Corp.2015-04-14
VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030)Stryker Corp.2015-04-13
VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029)Stryker Corp.2014-12-12
VITAGEL RT3 DELIVERY SYSTEM (P050044/S028)Stryker Corp.2014-06-05
VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026)Stryker Corp.2014-02-11
RT3 SURGICAL HEMOSTAT (P050044/S027)Stryker Corp.2014-01-27