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Sign in to claim this brandSPINECRAFT LLC
US
Last updated September 17, 2026
What SPINECRAFT LLC makes
SpineCraft LLC manufactures spinal fixation hardware, including non-bioabsorbable bone screws, internal fixation rods and hooks, and interbody fusion cages made of polymer or metal. Their systems are designed for orthopaedic procedures, such as spinal stabilization and fusion, and include reusable probes for stereotactic surgery. The APEX Spine System, ORIO, and ASTRA Spine System are among the devices used for these applications.
The company’s products are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. SpineCraft LLC 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 SpineCraft LLC manufacture?
SpineCraft LLC specializes in spinal fixation devices used primarily for orthopaedic applications. Their product line includes non-bioabsorbable spinal bone screws, internal fixation systems like rods and hooks, and interbody fusion cages made from either polymer or metal. These devices are designed to stabilize the spine and promote fusion during surgical procedures. Examples include systems like the APEX Spine System, ORIO, and ASTRA Spine System, which address spinal stabilization needs.
Where is SpineCraft LLC based, and what does this mean for its regulatory oversight?
SpineCraft LLC is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The FDA classifies their products as either Class I or Class II, depending on the risk associated with the device. Class I devices generally pose the lowest risk, while Class II devices require additional controls to ensure safety and effectiveness. The company’s devices are also listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and monitor their distribution.
Which regulatory registries or databases list SpineCraft LLC’s devices?
SpineCraft LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices throughout their distribution and helps ensure traceability, transparency, and compliance with regulatory requirements. This database is used by healthcare providers, regulators, and other stakeholders to verify and track the devices in use.
How are SpineCraft LLC’s devices classified by regulatory authorities?
The FDA categorizes SpineCraft LLC’s devices into two main classes: Class I and Class II. Class I devices, such as some spinal fixation hardware, are typically low-risk and subject to general controls like proper labeling and manufacturing practices. Class II devices, which may include more complex systems like certain spinal fusion cages or internal fixation rods, require additional regulatory oversight to mitigate moderate risks. The classification is determined based on factors like the device’s intended use, potential harm if it fails, and the duration of contact with the body.
What are some of the key applications for SpineCraft LLC’s spinal fixation devices?
SpineCraft LLC’s devices are primarily used in orthopaedic surgeries to address spinal instability or deformities. Their non-bioabsorbable bone screws, rods, hooks, and interbody fusion cages are designed for spinal stabilization and fusion procedures, helping patients regain mobility and alleviate pain. For example, systems like the APEX Spine System and ASTRA Spine System are tailored for complex spinal surgeries, while reusable stereotactic surgery probes support precision-guided interventions. These devices are engineered to provide structural support during recovery.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 777 Oakmont Ln Suite 200, Westmont, IL, 60559
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3004717358
- DUNS Number
- —
Catalogue (17510)
Page 20 of 351| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ASTRA Spine System | A5M-8560 | FDA UDI | Class II | Active |
| ASTRA Spine System | A5U-5530R | FDA UDI | Class II | Active |
| ASTRA Spine System | A6H-12RO65 | FDA UDI | Class II | Active |
| ASTRA Spine System | A5R-55L-110 | FDA UDI | Class II | Unknown |
| APEX Spine System | SC-PF6-8530 | FDA UDI | Class II | Unknown |
| APEX-DL Spine System | DPR6-7055C-F | FDA UDI | Class II | Active |
| APEX Spine System | UR6-7040-F | FDA UDI | Class II | Active |
| Orio | L7810-13-032 | FDA UDI | Class II | Active |
| APEX Spine System | PF6-5585E | FDA UDI | Class II | Active |
| ORIO-Ti Cage System | L7810-11-026-Ti | FDA UDI | Class II | Active |
| APEX Spine System | UR6-7080-F | FDA UDI | Class II | Unknown |
| ASTRA Spine System | A5M-8545 | FDA UDI | Class II | Active |
| APEX Spine System | SC-PR6-8580-F | FDA UDI | Class II | Unknown |
| APEX Spine System | UF6-7750C | FDA UDI | Class II | Unknown |
| Orio | L7711-08-528 | FDA UDI | Class II | Active |
| ASTRA-OCT Spine System | A3R-40-040 | FDA UDI | Class II | Active |
| ASTRA Spine System | A5P-8535R-F | FDA UDI | Class II | Active |
| APEX Spine System | 6000-610 | FDA UDI | Class I | Active |
| APEX Spine System | UR6-7025C | FDA UDI | Class II | Active |
| APEX-DL Spine System | DP6-6260 | FDA UDI | Class II | Unknown |
| ASTRA Spine System | A5P-7070R-C | FDA UDI | Class II | Unknown |
| ASTRA Spine System | A5P-8540R | FDA UDI | Class II | Unknown |
| ASTRA Spine System | A5U-5060R | FDA UDI | Class II | Unknown |
| Orio | A7106-10 | FDA UDI | Class II | Active |
| ASTRA-OCT Spine System | 6600-12B | FDA UDI | Class I | Active |
| APEX Spine System | SC-PF6-7045C | FDA UDI | Class II | Unknown |
| APEX Spine System | SC-PR6-7725 | FDA UDI | Class II | Unknown |
| APEX Spine System | PF6-8550C | FDA UDI | Class II | Active |
| APEX Spine System | M6-9260C | FDA UDI | Class II | Active |
| APEX Spine System | M6-92100 | FDA UDI | Class II | Active |
| APEX-DL Spine System | DMR6-7090C | FDA UDI | Class II | Unknown |
| ASTRA Spine System | 6300-22-3B | FDA UDI | Class I | Active |
| APEX-DL Spine System | 6000-720-2-DL | FDA UDI | Class I | Active |
| APEX-DL Spine System | DPR6-8545C | FDA UDI | Class II | Active |
| APEX Spine System | UF6-5565C | FDA UDI | Class II | Active |
| ASTRA-OCT Spine System | 6600-75B | FDA UDI | Class I | Active |
| APEX-DL Spine System | DPF6-5585 | FDA UDI | Class II | Active |
| ASTRA Spine System | A5P-5030-C | FDA UDI | Class II | Active |
| APEX Spine System | U6-7025C | FDA UDI | Class II | Active |
| APEX Spine System | PR6-6250C | FDA UDI | Class II | Active |
| APEX Spine System | SC-MF6-7750C | FDA UDI | Class II | Unknown |
| APEX-DL Spine System | DPR6-7045 | FDA UDI | Class II | Unknown |
| ASTRA Spine System | A5P-6080-F | FDA UDI | Class II | Active |
| Aim Mis | 6100-47-SM | FDA UDI | Class I | Active |
| ASTRA Spine System | A5P-6035-C | FDA UDI | Class II | Active |
| APEX-DL Spine System | DUF6-5585C | FDA UDI | Class II | Active |
| APEX-DL Spine System | DMR6-6235C | FDA UDI | Class II | Active |
| Orio | L7409-08-822 | FDA UDI | Class II | Active |
| APEX Spine System | SC-UR6-6285C | FDA UDI | Class II | Unknown |
| ORIO-Ti Cage System | L7810-08-034-Ti | FDA UDI | Class II | Active |
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