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510(k) K111983

VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX by Zimmer Trabecular Metal Technology — Product Code ODP

K111983 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular Metal Technology for the device "VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX". The FDA issued a decision of Substantially Equivalent on November 18, 2011. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Zimmer Trabecular Metal Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2011
Date Received
July 12, 2011
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 Zimmer Trabecular Metal Technology

  • K133784 — VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION (July 7, 2014)
  • K123602 — TM ARDIS INTERBODY SYSTEM INSERTER (March 1, 2013)
  • K120990 — NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LC (June 29, 2012)
  • K120203 — TM-400 DEVICE (June 15, 2012)
  • K113561 — TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION (May 29, 2012)
  • K103517 — TRABECULAR METAL FEMORAL CONE AUGMENTS (February 15, 2011)
  • K103033 — TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX (January 10, 2011)
  • K102896 — TRABECULAR METAL TIBIAL CONE AUGMENTS (December 13, 2010)
  • K093127 — TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET (March 4, 2010)
  • K070754 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 (August 31, 2007)

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