Home / 510(k) Clearances / K112316

510(k) K112316

4-WEB ALIF SPINAL TRUSS SYSTEM (STS) by 4-Web, Inc. — Product Code MAX

K112316 is an FDA 510(k) premarket notification submitted by 4-Web, Inc. for the device "4-WEB ALIF SPINAL TRUSS SYSTEM (STS)". The FDA issued a decision of Substantially Equivalent on December 14, 2011. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. 4-Web, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2011
Date Received
August 11, 2011
Clearance Type
Special
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 4-Web, Inc.

  • K130185 — 4WEB OSTEOTOMY BONE WEDGE (June 7, 2013)
  • K121741 — 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) (October 18, 2012)

Other clearances for product code MAX

  • 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)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources