510(k) Report

FDA applicant

Eisertech, LLC

San Diego, CA8 decisions2011–20191 recall

FDA records 8 decisions for Eisertech, LLC (San Diego, CA) from 2011 to 2019: 8 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 18 predicates, 3 of them its own earlier devices. 1 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 Eisertech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2011: 12012: 32015: 22019: 2
2011high 3 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2011high 1 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Eisertech, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eisertech, 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 Body2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • JDWPin, Fixation, Threaded1decision

Whose devices does it build on?

Its devices cite 18 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 3 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.

  • K113478Plif CageEisertech, LLC · 20128cite it
  • K140348Interbody CageEisertech, LLC · 20154cite it
  • K122444Cervical CageEisertech, LLC · 20122cite it
  • K142576Spinal SystemEisertech, LLC · 20151cites it
  • K113170Cervical PlateEisertech, LLC · 20121cites it
  • K192768Temporary Fixation PinsEisertech, LLC · 20191cites it

What has FDA decided for it lately?

  • K192768Temporary Fixation PinsEisertech, LLC · 2019
  • K190565Cervical PlateEisertech, LLC · 2019
  • K140348Interbody CageEisertech, LLC · 2015
  • K142576Spinal SystemEisertech, LLC · 20151 recall
  • K122444Cervical CageEisertech, LLC · 2012
  • K113170Cervical PlateEisertech, LLC · 2012
  • K113478Plif CageEisertech, LLC · 2012
  • K110915Cervical CageEisertech, LLC · 2011

All 8 as Eisertech, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142576Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System…May 21, 2015Class II