510(k) Report

FDA applicant

Interbody Innovations, Llp

Round Rock, TX4 decisions2005–20080 recalls

FDA records 4 decisions for Interbody Innovations, Llp (Round Rock, TX) from 2005 to 2008: 4 510(k) clearances. Most are in product codes NVR (Intervertebral Fusion Device With Bone Graft…) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 6 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 Interbody Innovations, Llp’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Interbody Innovations, Llp 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?

  • NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • JDKProsthesis, Hip, Cement Restrictor1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K081614Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar CagesInterbody Innovations, Llp · 20089cite it
  • K062992Spinal SpheresInterbody Innovations, Llp · 20071cites it

What has FDA decided for it lately?

  • K081614Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar CagesInterbody Innovations, Llp · 2008
  • K073105Peek Spinal SpheresInterbody Innovations, Llp · 2008
  • K062992Spinal SpheresInterbody Innovations, Llp · 2007
  • K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp · 2005

All 4 as Interbody Innovations, Llp →