510(k) Report

FDA applicant

Abbott Spine, Inc.

Austin, TX13 decisions2005–200912 recalls

FDA records 13 decisions for Abbott Spine, Inc. (Austin, TX) from 2005 to 2009: 13 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 13 predicates, 2 of them its own earlier devices. 12 recalls are linked to its devices, 1 Class I.

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 Abbott Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22008: 32009: 1
2007high 3 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2012

2008: 32009: 22010: 12011: 12012: 1, 1 Class I
2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Abbott Spine, Inc.’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?

  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • MNIOrthosis, Spinal Pedicle Fixation3decisions
  • KWPAppliance, Fixation, Spinal Interlaminal2decisions
  • JDQCerclage, Fixation2decisions
  • KNWInstrument, Biopsy1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Also: MAX (1).

Whose devices does it build on?

Its devices cite 13 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 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.

  • K073202Ardis SpacerAbbott Spine, Inc. · 200811cite it
  • K082032Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310)Abbott Spine, Inc. · 20088cite it
  • K060009Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 20068cite it
  • K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 20084cite it
  • K090060Nexlink Oct System, Model 7000 SeriesAbbott Spine, Inc. · 20093cite it
  • K052566Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120. Nex-Link Spinal…Abbott Spine, Inc. · 20063cite it

What has FDA decided for it lately?

  • K090060Nexlink Oct System, Model 7000 SeriesAbbott Spine, Inc. · 2009
  • K082032Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310)Abbott Spine, Inc. · 20081 recall
  • K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
  • K073202Ardis SpacerAbbott Spine, Inc. · 20081 Class I recall
  • K072672Sequoia Spinal System, Model 3300 SeriesAbbott Spine, Inc. · 20072 recalls
  • K071174Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc. · 20074 recalls
  • K062505Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesAbbott Spine, Inc. · 2006
  • K060634Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 SeriesAbbott Spine, Inc. · 20064 recalls

All 13 as Abbott Spine, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K073202Zimmer Spine Ardis Inserter, Rx, non-sterileNov 12, 2012Class I
  • K072672Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine…Apr 4, 2011
  • K030625Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label…Apr 13, 2010
  • K082032Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1.…Aug 20, 2009
  • K030625Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured…Jan 12, 2009
  • K030625PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott…Apr 17, 2008

Other applicant names beginning “Abbott”

FDA records each applicant name separately; these may or may not be the same firm.

Abbott Laboratories 920Abbott Medical 92Abbott Vascular 64Abbott Diabetes Care, Inc. 42Abbott Molecular, Inc. 33Abbott Diagnostics 28Abbott Point of Care, Inc. 22Abbott Medical Optics, Inc. 16Abbott Mfg., Inc. 14Abbott 14Abbott Diagnostics Scarborough, Inc. 8Abbott Ireland Diagnostics Division 8