FDA applicant

Ortho-Space, Ltd.

Caesarea, IL1 decision2021–20210 recalls

FDA records 1 decision for Ortho-Space, Ltd. (Caesarea, IL) in 2021: 1 De Novo grant. All are in product code QPQ (Shoulder Spacer For Massive Irreparable…). No 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 Ortho-Space, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ortho-Space, Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ortho-Space”

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

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Diagnostics, Inc. 24 Ortho Tec, LLC 22 Ortho Pharmaceutical Corp. 9 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Instruments 6 Ortho Kinematics, Inc. 6

Ortho-Space, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ortho-Space”