510(k) Report

FDA applicant

Innovative Spinal Technologies, Inc.

Mansfield, MA4 decisions2005–20070 recalls

FDA records 4 decisions for Innovative Spinal Technologies, Inc. (Mansfield, MA) from 2005 to 2007: 4 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 9 predicates, 1 of them its own earlier devices. No 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 Innovative Spinal Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovative Spinal Technologies, Inc. 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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • MQPSpinal Vertebral Body Replacement Device1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

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 16 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.

  • K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 20078cite it
  • K053276Ist Pedicle Screw SystemInnovative Spinal Technologies, Inc. · 20054cite it
  • K072650Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc. · 20073cite it
  • K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 20071cites it

What has FDA decided for it lately?

  • K072650Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc. · 2007
  • K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  • K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  • K053276Ist Pedicle Screw SystemInnovative Spinal Technologies, Inc. · 2005

All 4 as Innovative Spinal Technologies, Inc. →