Atlas FDA

WAGNER CONE PROSTHESIS SYSTEM

FDA 510(k) clearance K113556 · decided 2012-02-17

Clearance details

K-number
K113556
Device name
WAGNER CONE PROSTHESIS SYSTEM
Applicant
Zimmer GmbH
Decision
Substantially Equivalent
Date received
2011-12-01
Decision date
2012-02-17
Days to decision
78 days
Clearance type
Special
Product code
LZO
Device class
2
Regulation number
888.3353
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Wagner cone Prosthesis, uncemented, sterile, Rx recall (Z-0221-2013)Zimmer, Inc.2012-11-06