510(k) Report

FDA applicant

Medtronic Sofamor Danck USA, Inc.

Memphis, TN4 decisions2011–20150 recalls

FDA records 4 decisions for Medtronic Sofamor Danck USA, Inc. (Memphis, TN) from 2011 to 2015: 4 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and NDN (Cement, Bone, Vertebroplasty). Its devices cite 9 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 Medtronic Sofamor Danck USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 22014: 12015: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Medtronic Sofamor Danck USA, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Sofamor Danck USA, Inc.’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?

  • NKBThoracolumbosacral Pedicle Screw System2decisions
  • NDNCement, Bone, Vertebroplasty1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 0 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.

  • K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 20115cite it
  • K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 20115cite it
  • K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 20152cite it
  • K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 20142cite it

What has FDA decided for it lately?

  • K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
  • K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
  • K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
  • K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011

All 4 as Medtronic Sofamor Danck USA, Inc. →