510(k) Report

FDA applicant

4-Web, Inc.

Apple Valley, MN3 decisions2011–20131 recall

FDA records 3 decisions for 4-Web, Inc. (Apple Valley, MN) from 2011 to 2013: 3 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and HRS (Plate, Fixation, Bone). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided 4-Web, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12012: 12013: 1
2011high 1 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2011high 1 (2014) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — 4-Web, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 4-Web, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • HRSPlate, Fixation, Bone1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc. · 201111cite it
  • K1301854WEB Osteotomy Bone Wedge4-Web, Inc. · 20135cite it
  • K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 20124cite it

What has FDA decided for it lately?

  • K1301854WEB Osteotomy Bone Wedge4-Web, Inc. · 2013
  • K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012
  • K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc. · 20111 recall

All 3 as 4-Web, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K112316ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant)…Sep 29, 2014Class II