510(k) Report

FDA applicant

Allez Spine, LLC

Irvine, CA7 decisions2005–200930 recalls

FDA records 7 decisions for Allez Spine, LLC (Irvine, CA) from 2005 to 2009: 7 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 4 predicates, 2 of them its own earlier devices. 30 recalls are 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 Allez Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2009

2007: 12008: 12009: 3
2007high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

5in 2008

2007: 252008: 5
2007high 25 (2007) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Allez Spine, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Allez Spine, LLC’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?

  • NKBThoracolumbosacral Pedicle Screw System5decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 2 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.

  • K050060Laguna Pedicle Screw SystemAllez Spine, LLC · 20054cite it
  • K083826Laguna Polyaxial Pedicle Screw SystemAllez Spine, LLC · 20092cite it
  • K051275Laguna Monoaxial Pedicle Screw SystemAllez Spine, LLC · 20051cites it
  • K091219Del Mar Monoaxial Pedicle Screw SystemAllez Spine, LLC · 20091cites it
  • K091995Laguna Size 8 Pedicle Screw SystemAllez Spine, LLC · 20091cites it
  • K072678Laguna Size 8 Pedicle ScrewAllez Spine, LLC · 20081cites it

What has FDA decided for it lately?

  • K091995Laguna Size 8 Pedicle Screw SystemAllez Spine, LLC · 2009
  • K091219Del Mar Monoaxial Pedicle Screw SystemAllez Spine, LLC · 2009
  • K083826Laguna Polyaxial Pedicle Screw SystemAllez Spine, LLC · 2009
  • K072678Laguna Size 8 Pedicle ScrewAllez Spine, LLC · 2008
  • K070460Allez Spine Cross ConnectorsAllez Spine, LLC · 20071 recall
  • K051275Laguna Monoaxial Pedicle Screw SystemAllez Spine, LLC · 200521 recalls
  • K050060Laguna Pedicle Screw SystemAllez Spine, LLC · 200527 recalls

All 7 as Allez Spine, LLC →

What has been recalled?

30 recalls linked to its devices; the latest:

  • K051275Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw…Aug 21, 2008
  • K070460Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm…Aug 21, 2008
  • K050060Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw…Aug 21, 2008
  • K051275Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part…Apr 14, 2008
  • K050060Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part…Apr 14, 2008
  • K050060Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x…Nov 7, 2007