Medical Device Manufacturer · KR , Uijungbu, Gyeonggi-Do

U&I Corp. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2005

Recent clearances: VELOXTM INTERBODY FUSION SYSTEM, ASPIRON ACP SYSTEM, VELOFIXTM INTERBODY FUSION SYSTEM

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - U&I Corp. Orthopedic ✕

12 devices

1-12 of 12

Cleared Jul 22, 2014

VELOXTM INTERBODY FUSION SYSTEM

Orthopedic · 110d

Cleared Jun 02, 2014

ASPIRON ACP SYSTEM

Orthopedic · 124d

Cleared Mar 05, 2014

VELOFIXTM INTERBODY FUSION SYSTEM

Orthopedic · 168d

Cleared May 21, 2012

DYNA LOCKING ANKLE NAIL

Orthopedic · 101d

Cleared Jan 04, 2012

DYNA LOCKING CANNULATED SCREW

Orthopedic · 153d

Cleared Dec 08, 2010

OPTIGEN TOTAL KNEE SYSTEM

Orthopedic · 110d

Cleared Jun 23, 2010

DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820

Orthopedic · 203d

Cleared Dec 02, 2009

DYNA LOCKING IM NAIL

Orthopedic · 84d

Cleared Nov 09, 2009

PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)

Orthopedic · 151d

Cleared Nov 15, 2006

MAXIMA ANTERIOR CERVICAL PLATE SYSTEM

Orthopedic · 218d

Cleared Aug 04, 2005

OPTIMA SPINAL SYSTEM

Orthopedic · 14d

Cleared Feb 17, 2005

MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM

Orthopedic · 118d