510(k) Report

FDA applicant

Rsb Spine, LLC

Chesterland, OH7 decisions2006–20100 recalls

FDA records 7 decisions for Rsb Spine, LLC (Chesterland, OH) from 2006 to 2010: 7 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 5 predicates, 2 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 Rsb Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 32008: 12009: 12010: 1
2007high 3 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • MQPSpinal Vertebral Body Replacement Device3decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 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.

  • K071922Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 20075cite it
  • K092070Interplate CRsb Spine, LLC · 20094cite it
  • K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC · 20102cite it
  • K081194Interplate Peek Cervical Interbody Fusion Device (Ifd)Rsb Spine, LLC · 20082cite it

What has FDA decided for it lately?

  • K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC · 2010
  • K092070Interplate CRsb Spine, LLC · 2009
  • K081194Interplate Peek Cervical Interbody Fusion Device (Ifd)Rsb Spine, LLC · 2008
  • K071922Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
  • K071372Modification to: Interplate VBR SystemRsb Spine, LLC · 2007
  • K070316Interplate VBR SystemRsb Spine, LLC · 2007
  • K061401Interplate VBR SystemRsb Spine, LLC · 2006

All 7 as Rsb Spine, LLC →