Medical Device Manufacturer · KR , Uijungbu, Gyeonggi-Do

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

12 submissions · 12 cleared · Since 2005
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
1-12 of 12
Cleared Jul 22, 2014
VELOXTM INTERBODY FUSION SYSTEM
K140864 · ODP
Orthopedic · 110d
Cleared Jun 02, 2014
ASPIRON ACP SYSTEM
K140234 · KWQ
Orthopedic · 124d
Cleared Mar 05, 2014
VELOFIXTM INTERBODY FUSION SYSTEM
K132926 · ODP
Orthopedic · 168d
Cleared May 21, 2012
DYNA LOCKING ANKLE NAIL
K120419 · HSB
Orthopedic · 101d
Cleared Jan 04, 2012
DYNA LOCKING CANNULATED SCREW
K112240 · HWC
Orthopedic · 153d
Cleared Dec 08, 2010
OPTIGEN TOTAL KNEE SYSTEM
K102367 · JWH
Orthopedic · 110d
Cleared Jun 23, 2010
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
K093707 · HSB
Orthopedic · 203d
Cleared Dec 02, 2009
DYNA LOCKING IM NAIL
K092771 · HSB
Orthopedic · 84d
Cleared Nov 09, 2009
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
K091725 · MNH
Orthopedic · 151d
Cleared Nov 15, 2006
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
K061002 · KWQ
Orthopedic · 218d
Cleared Aug 04, 2005
OPTIMA SPINAL SYSTEM
K051971 · KWQ
Orthopedic · 14d
Cleared Feb 17, 2005
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K042928 · MNH
Orthopedic · 118d
Filters
Filter by Specialty
All12 Orthopedic 12