FDA applicant

Aesculap Implants Systems, LLC

Center Valley, PA4 decisions2015–20230 recalls

FDA records 4 decisions for Aesculap Implants Systems, LLC (Center Valley, PA) from 2015 to 2023: 4 510(k) clearances. Most are in product codes QLQ (Manual Instruments Designed For Use With Total…) and PLR (Spinal Vertebral Body Replacement Device -…). Its devices cite 28 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Aesculap Implants Systems, Inc.”.

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 Aesculap Implants Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Aesculap Implants Systems, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aesculap Implants Systems, 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 “Aesculap”

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

Aesculap, Inc. 219 Aesculap Implant Systems, LLC 51 Aesculap Implant System, Inc. 18 Aesculap Instruments Corp. 13 Aesculap-Meditec North America 6 Aesculap-Meditec GmbH 3

Aesculap Implants Systems, 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?

Other applicant names beginning “Aesculap”