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U&I CORP.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2672-2020Class IIANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEMMay 26, 2020
Z-1823-2020Class IIVelofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSAJanuary 30, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K140864VELOXTM INTERBODY FUSION SYSTEMJuly 22, 2014
K140234ASPIRON ACP SYSTEMJune 2, 2014
K132926VELOFIXTM INTERBODY FUSION SYSTEMMarch 5, 2014
K120419DYNA LOCKING ANKLE NAILMay 21, 2012
K112240DYNA LOCKING CANNULATED SCREWJanuary 4, 2012
K102367OPTIGEN TOTAL KNEE SYSTEMDecember 8, 2010
K093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820June 23, 2010
K092771DYNA LOCKING IM NAILDecember 2, 2009
K091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)November 9, 2009
K061002MAXIMA ANTERIOR CERVICAL PLATE SYSTEMNovember 15, 2006
K051971OPTIMA SPINAL SYSTEMAugust 4, 2005
K042928MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEMFebruary 17, 2005