FDA applicant

Apollo Spine, Inc.

Stoughton, MA7 decisions2009–20120 recalls

FDA records 7 decisions for Apollo Spine, Inc. (Stoughton, MA) from 2009 to 2012: 7 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Apollo Spine”.

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

FDA decisions per year

2in 2012

2009high 3 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Apollo Spine, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Apollo 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

Other applicant names beginning “Apollo”

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

Apollo Endosurgery, Inc. 14 Apollo Enterprise, Ltd. Co. 3 Apollo Medical Imaging Technology Pty., Ltd. 2 Apollo Dental Products, Inc. 2 Apollo Products, Inc. 1 Apollo'S Suntanning Supplies 1 Apollo Medical Optics, Ltd. 1 Apollo Fluid Dynamics 1 Apollo Corp. 1 Apollo Physical Therapy Products International 1

Apollo Spine, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Apollo”