510(k) Report

FDA applicant

Orbbo Surgical, LLC

Los Angeles, CA4 decisions2016–20170 recalls

FDA records 4 decisions for Orbbo Surgical, LLC (Los Angeles, CA) from 2016 to 2017: 4 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 55 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Orbbo Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2017

2016: 12017: 3
2016high 3 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Orbbo Surgical, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orbbo Surgical, 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?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 55 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K163265Kepler IIOrbbo Surgical, LLC · 2017
  • K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC · 2017
  • K163566Hubble I SystemOrbbo Surgical, LLC · 2017
  • K163180Hubble IIOrbbo Surgical, LLC · 2016

All 4 as Orbbo Surgical, LLC →