U&I CORP.
FDA Regulatory Profile
U&I CORP. appears in FDA public data with 2 recalls, 12 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2672-2020, Class II) was initiated on May 26, 2020. Its most recent 510(k) clearance was granted on July 22, 2014.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2672-2020 | Class II | ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM | May 26, 2020 |
| Z-1823-2020 | Class II | Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA | January 30, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140864 | VELOXTM INTERBODY FUSION SYSTEM | July 22, 2014 |
| K140234 | ASPIRON ACP SYSTEM | June 2, 2014 |
| K132926 | VELOFIXTM INTERBODY FUSION SYSTEM | March 5, 2014 |
| K120419 | DYNA LOCKING ANKLE NAIL | May 21, 2012 |
| K112240 | DYNA LOCKING CANNULATED SCREW | January 4, 2012 |
| K102367 | OPTIGEN TOTAL KNEE SYSTEM | December 8, 2010 |
| K093707 | DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 | June 23, 2010 |
| K092771 | DYNA LOCKING IM NAIL | December 2, 2009 |
| K091725 | PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) | November 9, 2009 |
| K061002 | MAXIMA ANTERIOR CERVICAL PLATE SYSTEM | November 15, 2006 |
| K051971 | OPTIMA SPINAL SYSTEM | August 4, 2005 |
| K042928 | MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM | February 17, 2005 |