Atlas FDA

ACCOLADE II HIP STEM

FDA 510(k) clearance K120578 · decided 2012-03-29

Clearance details

K-number
K120578
Device name
ACCOLADE II HIP STEM
Applicant
Howmedica Osteonics
Decision
Substantially Equivalent
Date received
2012-02-27
Decision date
2012-03-29
Days to decision
31 days
Clearance type
Special
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mahwah, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, S recall (Z-0467-2014)Stryker Howmedica Osteonics Corp.2013-12-07