Atlas FDA

FOUNDATION 9MM FORGED CEMENTED STEM

FDA 510(k) clearance K961890 · decided 1996-06-14

Clearance details

K-number
K961890
Device name
FOUNDATION 9MM FORGED CEMENTED STEM
Applicant
Encore Orthopedics, Inc.
Decision
Substantially Equivalent
Date received
1996-05-15
Decision date
1996-06-14
Days to decision
30 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 M recall (Z-0418-2012)Encore Medical, Lp2012-01-11