U&I Corp.
U&I Corp. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2014, with 2 FDA device recalls on record.
Top product codes for U&I Corp.
FDA recalls by U&I Corp.
- Z-2672-2020 — ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
- Z-1823-2020 — Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by U&I Corp.
- K140864 — VELOXTM INTERBODY FUSION SYSTEM
- K140234 — ASPIRON ACP SYSTEM
- K132926 — VELOFIXTM INTERBODY FUSION SYSTEM
- K120419 — DYNA LOCKING ANKLE NAIL
- K112240 — DYNA LOCKING CANNULATED SCREW
- K102367 — OPTIGEN TOTAL KNEE SYSTEM
- K093707 — DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
- K092771 — DYNA LOCKING IM NAIL
- K091725 — PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
- K061002 — MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
- K051971 — OPTIMA SPINAL SYSTEM
- K042928 — MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.