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Sign in to claim this brandSafe Orthopaedics
US
Last updated May 23, 2026
What Safe Orthopaedics makes
Safe Orthopaedics manufactures non-bioabsorbable spinal bone screws and metallic spinal interbody fusion cages for surgical fusion procedures. The company also produces orthopaedic surgical procedure kits designed for single-use applications without medication.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Safe Orthopaedics manufacture?
Safe Orthopaedics specializes in spinal orthopaedic devices. Their primary products include non-bioabsorbable spinal bone screws, metallic spinal interbody fusion cages (used in surgical fusion procedures), and orthopaedic surgical procedure kits that are intended for single-use and non-medicated applications. These devices are designed to support spinal stability and fusion during orthopaedic surgeries.
Where is Safe Orthopaedics based?
Safe Orthopaedics is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US-based medical device standards.
How are Safe Orthopaedics’ devices classified under FDA regulations?
Safe Orthopaedics’ devices are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as spinal fixation devices. The classification influences the regulatory pathway and post-market surveillance requirements.
Are Safe Orthopaedics’ devices listed in any regulatory registries?
Yes, Safe Orthopaedics’ devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory compliance. This listing is essential for traceability and post-market monitoring.
What is the purpose of the orthopaedic surgical procedure kits produced by Safe Orthopaedics?
Safe Orthopaedics’ orthopaedic surgical procedure kits are designed for single-use applications and are non-medicated, meaning they do not contain drugs or pharmaceuticals. These kits are likely intended to streamline surgical workflows by bundling essential tools and components required for specific orthopaedic procedures, such as spinal fusion surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 261875917
Catalogue (409)
Page 7 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sterispine Ps | KITACL445 | FDA UDI | Class II | Active |
| Sterispine Ps | KITRMI370S | FDA UDI | Class II | Active |
| Sterispine Ps | KITRMI200S | FDA UDI | Class II | Active |
| Sterispine Ps | KITMCL630 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMF460 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS30-14 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS32-11 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMC660 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMCL435 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS22-11 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMCL550 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMCL780 | FDA UDI | Class II | Active |
| Sterispine Ps | KITACL755 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMC455 | FDA UDI | Class II | Active |
| Sterispine Ps | KITM625 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMFL460 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS22-14 | FDA UDI | Class II | Active |
| Sterispine Ps | KITM465 | FDA UDI | Class II | Active |
| Sterispine Ps | KITACL780 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMFL745 | FDA UDI | Class II | Active |
| Sterispine Ps | KITM480 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMF430 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMC425 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS26-10 | FDA UDI | Class II | Active |
| Sterispine Ps | KITACL470 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS32-09 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCC28-11 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMC775 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMCL680 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS24-11 | FDA UDI | Class II | Active |
| Sterispine Lc | KITANCLC | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS32-13 | FDA UDI | Class II | Active |
| Sterispine Ps | KITM445 | FDA UDI | Class II | Active |
| Sterispine Ps | KITACL635 | FDA UDI | Class II | Active |
| Sterispine Cc | KITCCS10L | FDA UDI | Class II | Active |
| Sterispine Ps | KITM545 | FDA UDI | Class II | Active |
| Sterispine Ps | KITACL485 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCS30-08 | FDA UDI | Class II | Active |
| Sterispine Ps | KITACL660 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMCL725 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMF630 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMC770 | FDA UDI | Class II | Active |
| Sterispine Ps | KITRMI100S | FDA UDI | Class II | Active |
| Sterispine Ps | KITMFL655 | FDA UDI | Class II | Active |
| Sterispine Ps | KITACL625 | FDA UDI | Class II | Active |
| Sterispine Ps | KITRMI320S | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCC28-14 | FDA UDI | Class II | Active |
| Sterispine Lc | KITLCC30-14 | FDA UDI | Class II | Active |
| Sterispine Ps | KITMCL665 | FDA UDI | Class II | Active |
| Sterispine Ps | KITRMI330S | FDA UDI | Class II | Active |
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