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510(k) K141405

MOBIS II ST SPINAL IMPLANT by Signus Medizintechnik GmbH — Product Code MAX

K141405 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik GmbH for the device "MOBIS II ST SPINAL IMPLANT". The FDA issued a decision of Substantially Equivalent on September 16, 2014. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Signus Medizintechnik GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2014
Date Received
May 28, 2014
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

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

Other clearances by Signus Medizintechnik GmbH

  • K243188 — CYLOX® ST (February 11, 2025)
  • K241438 — Signus Tetris™ St; Signus Tetris™ R St (September 11, 2024)
  • K220658 — COSY Cervicothoracic Occipital Rod-Screw System (November 18, 2022)
  • K212755 — SIGNUS SACRONAIL® Transsacral Stabilization System (March 10, 2022)
  • K203327 — VERTACONNECT TLIF Cage (January 25, 2021)
  • K151704 — Diplomat® Spinal System (April 13, 2016)
  • K123758 — TASMIN R (January 14, 2014)
  • K131372 — MOBIS II (July 2, 2013)
  • K122317 — TETRIS II (August 29, 2012)
  • K111792 — MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MI (March 5, 2012)

Other clearances for product code MAX

  • K261049 — SCALA® TL (August 20, 2026)
  • K261430 — TruLift Expandable System (July 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 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