510(k) Report

FDA applicant

Alphatec/Nexmed

Carlsbad, CA9 decisions2004–20054 recalls

FDA records 9 decisions for Alphatec/Nexmed (Carlsbad, CA) from 2004 to 2005: 9 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and MQP (Spinal Vertebral Body Replacement Device). Its devices cite 10 predicates, 1 of them its own earlier devices. 4 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 Alphatec/Nexmed’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alphatec/Nexmed since 2007.

Recalls per year

1in 2012

2007: 12008: 12011: 12012: 1
2007high 1 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation2decisions
  • MQPSpinal Vertebral Body Replacement Device2decisions
  • KWPAppliance, Fixation, Spinal Interlaminal2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision
  • HSBRod, Fixation, Intramedullary And Accessories1decision

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 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.

  • K042673Zodiac Polyaxial Spinal Fixation SystemAlphatec/Nexmed · 200413cite it
  • K050553Novel VBR Spinal SystemAlphatec/Nexmed · 20058cite it
  • K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed · 20056cite it
  • K042201Novel VBR Spinal SystemAlphatec/Nexmed · 20045cite it

What has FDA decided for it lately?

  • K050830Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
  • K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
  • K050553Novel VBR Spinal SystemAlphatec/Nexmed · 20051 recall
  • K050390Tamarack Anterior ThoracolunbarAlphatec/Nexmed · 2005
  • K050078Roc Lumbar Plating SystemAlphatec/Nexmed · 2005
  • K042252Nexflex Total Hip SystemAlphatec/Nexmed · 2004
  • K042673Zodiac Polyaxial Spinal Fixation SystemAlphatec/Nexmed · 20043 recalls
  • K042201Novel VBR Spinal SystemAlphatec/Nexmed · 2004

All 9 as Alphatec/Nexmed →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K042673ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System…Sep 25, 2012Class II
  • K042673ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY…Jul 6, 2011Class II
  • K042673Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a…Nov 3, 2008
  • K050553Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in…Aug 16, 2007

Other applicant names beginning “Alphatec/Nexmed”

FDA records each applicant name separately; these may or may not be the same firm.

Alphatec Spine, Inc. 102Alphatec Mfg., Inc. 20