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510(k) K191791

TranS1 Interbody Fusion System by Trans1 — Product Code MAX

K191791 is an FDA 510(k) premarket notification submitted by Trans1 for the device "TranS1 Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on Sep 25, 2019. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Trans1 has 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 25, 2019
Date Received
Jul 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type
510(k)

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

Other clearances by Trans1

  • K192792 — TranS1 AxiaLIF Plus System (Nov 20, 2019)
  • K123997 — TRANS1LATERAL INTERBODY FUSION SYSTEM (Apr 1, 2013)
  • K040426 — TRANS1 AXIAL FIXATION SYSTEM (Dec 17, 2004)
  • K032891 — TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT (Jan 15, 2004)

Other clearances for product code MAX

  • K261049 — SCALA® TL (Aug 20, 2026)
  • K261430 — TruLift Expandable System (Jul 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (Jul 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (Jul 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… (Jul 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (Jun 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)

FDA data resources