FDA applicant

Theken Surgical,Llc

Barberton, OH9 decisions1998–20052 recalls

FDA records 9 decisions for Theken Surgical,Llc (Barberton, OH) from 1998 to 2005: 9 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and JDK (Prosthesis, Hip, Cement Restrictor). Its devices cite 17 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Theken Surgical”.

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 Theken Surgical,Llc’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Theken Surgical,Llc since 2007.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Theken 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 “Theken”

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

Theken Spine, LLC 23 Theken Companies, LLC 5

Theken 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 “Theken”