Atlas FDA

Stryker Maestro Air Motors

FDA 510(k) clearance K150801 · decided 2015-05-22

Clearance details

K-number
K150801
Device name
Stryker Maestro Air Motors
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2015-03-26
Decision date
2015-05-22
Days to decision
57 days
Clearance type
Special
Product code
HBB
Device class
2
Regulation number
882.4370
Medical specialty
Neurology
Advisory committee
Neurology
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pne recall (Z-1939-2016)Stryker Instruments Div. of Stryker Corporation2016-06-09

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