Atlas FDA

STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM

FDA 510(k) clearance K132671 · decided 2013-12-20

Clearance details

K-number
K132671
Device name
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2013-08-27
Decision date
2013-12-20
Days to decision
115 days
Clearance type
Traditional
Product code
JCX
Device class
2
Regulation number
878.4780
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Was recall (Z-2282-2026)Stryker Corporation2026-06-01
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Pro recall (Z-2524-2015)Stryker Instruments Div. of Stryker Corporation2015-09-01
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001 recall (Z-2099-2015)Stryker Instruments Div. of Stryker Corporation2015-07-17
Neptune 2 Rover Ultra Waste Management System. recall (Z-0902-2014)Stryker Instruments Div. of Stryker Corporation2014-01-31
Neptune 2 Rover Ultra Waste Management System recall (Z-0903-2014)Stryker Instruments Div. of Stryker Corporation2014-01-31

PMA approvals by this applicant

RecordFirmDate
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19