U&I Corp. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
U&I Corp. - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
U&I Corp. has 12 FDA 510(k) cleared orthopedic devices. Based in Uijungbu, Gyeonggi-Do, KR.
Historical record: 12 cleared submissions from 2005 to 2014.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - U&I Corp.
12 devices
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