Atlas FDA

OMEGA II MODULAR TOTAL HIP SYSTEM

FDA 510(k) clearance K000817 · decided 2000-06-08

Clearance details

K-number
K000817
Device name
OMEGA II MODULAR TOTAL HIP SYSTEM
Applicant
Osteoimplant Technology, Inc.
Decision
Substantially Equivalent
Date received
2000-03-13
Decision date
2000-06-08
Days to decision
87 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Hunt Valley, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medic recall (Z-1868-2008)Encore Medical, Lp2008-08-26
ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0m recall (Z-1063-2007)Encore Medical, Lp2007-07-23
ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm recall (Z-1064-2007)Encore Medical, Lp2007-07-23
ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250m recall (Z-1065-2007)Encore Medical, Lp2007-07-23
ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 25 recall (Z-1066-2007)Encore Medical, Lp2007-07-23