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Sign in to claim this brandSPINESOURCE INC
US
Last updated May 24, 2026
What SPINESOURCE INC makes
SpineSource Inc manufactures reusable orthopaedic instruments for spinal surgery, including bone-resection reamers, metallic spinal interbody fusion cages, and implantation sleeves. Their portfolio also includes hammering attachments, implant inserters/extractors, and reusable surgical screwdrivers designed for spinal procedures. The company produces both sterile and non-sterile metallic spinal fusion cages, as well as devices for precise implant placement during surgical interventions.
The company’s devices are classified under FDA regulations as Class I and Class II, with most products listed in the FDA’s Unique Device Identifier (UDI) database. These instruments are intended for use in spinal fusion and orthopaedic surgeries, adhering to U.S. regulatory standards. SpineSource Inc 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 SpineSource Inc manufacture?
SpineSource Inc specializes in reusable orthopaedic instruments primarily for spinal surgery. Their product portfolio includes bone-resection orthopaedic reamers, metallic spinal interbody fusion cages (both sterile and non-sterile), orthopaedic implantation sleeves, hammering attachments, implant inserters/extractors, and reusable surgical screwdrivers. These devices are designed to assist in spinal fusion procedures and precise implant placement during surgical interventions.
Where is SpineSource Inc based?
SpineSource Inc is based in the United States. The company’s headquarters and operations are located within the country, aligning its manufacturing and regulatory compliance with U.S. standards.
Which regulatory registries or databases list SpineSource Inc’s devices?
SpineSource Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices under U.S. regulatory oversight, helping healthcare providers and authorities verify product details.
How are SpineSource Inc’s devices classified under FDA regulations?
SpineSource Inc’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose minimal risk and require less regulatory scrutiny, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the nature of the surgical procedure.
What is the primary purpose of SpineSource Inc’s reusable orthopaedic instruments?
SpineSource Inc’s reusable orthopaedic instruments are designed to facilitate spinal fusion and orthopaedic surgeries by enabling precise bone preparation, implant placement, and stabilization. Devices like bone-resection reamers and implantation sleeves ensure accurate surgical techniques, while reusable tools like screwdrivers and inserters/extractors enhance efficiency and reduce waste in the operating room.
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
- 150955560
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| L-Varlock | 165 | FDA UDI | Class II | Active |
| L-Varlock | 110 | FDA UDI | Class II | Active |
| L-Varlock | 004 | FDA UDI | Class II | Active |
| L-Varlock | 042 | FDA UDI | Class I | Active |
| L-Varlock | 158 | FDA UDI | Class II | Active |
| L-Varlock | 028 | FDA UDI | Class I | Active |
| L-Varlock | 127 | FDA UDI | Class I | Active |
| L-Varlock | 011 | FDA UDI | Class I | Active |
| L-Varlock | 080 | FDA UDI | Class I | Active |
| L-Varlock | 035 | FDA UDI | Class I | Active |
| L-Varlock | 134 | FDA UDI | Class II | Active |
| L-Varlock | 073 | FDA UDI | Class I | Active |
| L-Varlock | 059 | FDA UDI | Class I | Active |
| L-Varlock | 103 | FDA UDI | Class I | Active |
| L-Varlock | 097 | FDA UDI | Class I | Active |
| L-Varlock | 141 | FDA UDI | Class I | Active |
| L-Varlock | 066 | FDA UDI | Class I | Active |
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