ORTHO-SPACE LTD

Ortho-Space Ltd specializes in tendon spacers, with a focus on subacromial tissue spacer systems. Their primary product line consists of variations of the InSpace™ system, designed for surgical use in joint spaces. These devices aim to support tissue regeneration or reduce friction in orthopedic procedures, particularly for conditions affecting tendons and adjacent structures.

Ortho-Space Ltd is headquartered in Israel. While the company itself is based there, its devices are subject to regulatory oversight by both the European Union (via EUDAMED) and the U.S. Food and Drug Administration (FDA), as evidenced by their listings in the FDA’s 510(k) and UDI systems.

Ortho-Space Ltd’s devices are documented in multiple regulatory databases, including the EU’s EUDAMED registry for European compliance tracking, the FDA’s 510(k) clearance database (for premarket notifications in the U.S.), and the FDA’s Unique Device Identifier (UDI) system to ensure traceability and identification of medical devices.

Ortho-Space Ltd’s devices fall under Class II and Class III classifications, depending on the specific product. Class II devices typically involve moderate risk and require special controls beyond general controls, while Class III devices are higher risk (e.g., supporting life or sustaining/improving health) and require rigorous premarket approval. The classification determines the regulatory pathway and scrutiny applied.