510(k) Report

FDA applicant

Ahp Eos Buyer, Inc.

Parsippany4 decisions1979–19878 recalls

FDA records 4 decisions for Ahp Eos Buyer, Inc. (Parsippany) from 1979 to 1987: 4 original PMA approvals. Most are in product codes LOE (Stimulator, Invasive Bone Growth) and LOF (Stimulator, Bone Growth, Non-Invasive). 8 recalls are linked to its devices, 4 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 Ahp Eos Buyer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ahp Eos Buyer, Inc. since 2007.

Recalls per year

4in 2024

2017: 2, 2 Class I2018: 2, 2 Class I2024: 4
2007high 4 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • LOEStimulator, Invasive Bone Growth2decisions
  • LOFStimulator, Bone Growth, Non-Invasive2decisions

What has FDA decided for it lately?

  • P850035SpF® Implantable Spinal Fusion StimulatorAhp Eos Buyer, Inc. · 19873 Class I recalls
  • P850022Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion…Ahp Eos Buyer, Inc. · 19864 recalls
  • P790005OsteoGenTM Implantable Bone Growth StimulatorsAhp Eos Buyer, Inc. · 19801 Class I recall
  • P790002Biomet (R) EBI BONE Healing SystemAhp Eos Buyer, Inc. · 1979

All 4 as Ahp Eos Buyer, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • P85002248" Lead Wires, Replacement Part Number: 1067724-4Mar 22, 2024Class II
  • P85002220" Lead Wires, Replacement Part Number: 1067724-2Mar 22, 2024Class II
  • P850022Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the…Mar 22, 2024Class II
  • P850022Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment…Mar 22, 2024Class II
  • P790005EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth…Feb 19, 2018Class I
  • P850035SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable…Feb 19, 2018Class I