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510(k) K203327

VERTACONNECT TLIF Cage by Signus Medizintechnik — Product Code MAX

K203327 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik for the device "VERTACONNECT TLIF Cage". The FDA issued a decision of Substantially Equivalent on January 25, 2021. 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 has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2021
Date Received
November 12, 2020
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

  • 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)
  • K151704 — Diplomat® Spinal System (April 13, 2016)
  • K141405 — MOBIS II ST SPINAL IMPLANT (September 16, 2014)
  • 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