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510(k) K132926

VELOFIXTM INTERBODY FUSION SYSTEM by U&I Corp. — Product Code ODP

K132926 is an FDA 510(k) premarket notification submitted by U&I Corp. for the device "VELOFIXTM INTERBODY FUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 5, 2014. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. U&I Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2014
Date Received
September 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by U&I Corp.

  • K140864 — VELOXTM INTERBODY FUSION SYSTEM (July 22, 2014)
  • K140234 — ASPIRON ACP SYSTEM (June 2, 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)

Other clearances for product code ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources