FDA applicant

Apex Surgical, LLC

Lakeville, MA6 decisions2000–20051 recall

FDA records 6 decisions for Apex Surgical, LLC (Lakeville, MA) from 2000 to 2005: 6 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and LZO (Prosthesis, Hip, Semi-Constrained…). Its devices cite 15 predicates, 2 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 Apex Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Apex Surgical, LLC since 2007.

Recalls per year

1in 2021

2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Apex Surgical, 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

Other applicant names beginning “Apex”

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

Apex Medical Corp. 36 Apex BioTechnology Corp. 35 Apex Dental Materials, Inc. 15 Apex Medical Technologies, Inc. 8 Apex Metal, Inc. 3 Apex Tools & Orthopedics Co. 2 Apex Ent., Inc. 1 Apex Optical Ind. Co. 1 Apex Medical Products, LLC 1 Apex Technologies, Inc. 1 Apex Orthodontics, Inc. 1 Apex Imaging Corp. 1

Apex Surgical, LLC

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?

What has been recalled?

Other applicant names beginning “Apex”