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Sign in to claim this brandCAMBER SPINE TECHNOLOGIES
US
Last updated September 17, 2026
What CAMBER SPINE TECHNOLOGIES makes
The company manufactures spinal fixation hardware, including non-bioabsorbable screws, metallic and polymeric interbody fusion cages, spinal plates, and reusable instrument trays. It also produces spinal implant trial devices and ophthalmic surgical forceps for handling implants. Systems like the SPIRA®-T and ALTIVO™ are designed for anterior and lateral spinal fusion procedures, while the ORTHROS and Ti-Diagon devices support specific spinal stabilization applications.
These devices are regulated under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device regulations.
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 Camber Spine Technologies primarily manufacture?
Camber Spine Technologies specializes in spinal fixation hardware, including non-bioabsorbable screws, metallic and polymeric interbody fusion cages, spinal fixation plates, and reusable instrument trays. Their product line also includes spinal implant trial devices and ophthalmic surgical forceps designed for handling implants. Examples like the SPIRA®-T Integrated Fixation System and ALTIVO™ Anterior Cervical Fixation System focus on spinal fusion procedures, while devices such as ORTHROS and Ti-Diagon are tailored for stabilization applications.
Where is Camber Spine Technologies based, and how does this affect its regulatory compliance?
Camber Spine Technologies is based in the United States, meaning its devices are subject to U.S. medical device regulations. The company’s products fall under FDA classifications, with most devices categorized as Class I or Class II, which determines the regulatory pathway for authorization. Being U.S.-based also influences compliance with domestic manufacturing, labeling, and post-market surveillance requirements.
Which regulatory registries or databases list Camber Spine Technologies’ devices?
Camber Spine Technologies’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory oversight. Listing in this database is a requirement for devices marketed in the U.S., helping healthcare providers and regulators verify product details and compliance status.
How are Camber Spine Technologies’ devices classified under FDA regulations?
Camber Spine Technologies’ devices are classified under FDA’s risk-based system, with most falling into Class I (low-risk, general controls) or Class II (moderate-risk, requiring special controls). For example, reusable instrument trays and some spinal screws may qualify as Class I, while more complex systems like interbody fusion cages or fixation plates are typically Class II. This classification determines the regulatory scrutiny and authorization requirements each device must meet before market introduction.
What distinguishes Camber Spine Technologies’ spinal fusion systems from other similar products?
Camber Spine Technologies’ systems, such as the SPIRA®-T Integrated Fixation System and ALTIVO™ Anterior Cervical Fixation System, are designed with modularity and specific anatomical targeting in mind. For instance, the SPIRA®-L Open Matrix LLIF system is tailored for lateral lumbar interbody fusion (LLIF), while the ALTIVO™ system focuses on anterior cervical procedures. These distinctions often relate to material composition (e.g., metallic vs. polymeric cages), surgical approach, or integration with fixation hardware, allowing for tailored solutions in spinal stabilization and fusion.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 501 Allendale Rd, King of Prussia, PA, 19406
- 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
- 3010197239
- DUNS Number
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Catalogue (5147)
Page 37 of 103| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ORTHROS Open | ORT-1-6570 | FDA UDI | Class II | Active |
| Enza-O | EZO-2632-0809 | FDA UDI | Class II | Active |
| SPIRA®-A Integrated | SAZ-5555VD | FDA UDI | Class II | Active |
| Orthros | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 35mm Lg. | FDA UDI | Class II | Active |
| Orthros | Ø8.5mm Monoaxial Pedicle Screw, 100mm Lg. | FDA UDI | Class II | Active |
| SPIRA®-L Open Matrix LLIF | SPL-2650-0012 | FDA UDI | Class II | Active |
| Spira-L | SPL-102-027 | FDA UDI | Class I | Active |
| SPIRA®-A Integrated | SAZ-102-068 | FDA UDI | Class I | Active |
| Orthros Mis | CM-117-04 | FDA UDI | Class I | Active |
| SPIRA®-A Integrated | SAZ-2838-3021 | FDA UDI | Class II | Active |
| Orthros | Ø5.5mm Polyaxial Pedicle Screw, 25mm Lg. | FDA UDI | Class II | Active |
| Diagon | "Bi-Convex, 12mm x 34mm x 16mm, Oblique ASM" | FDA UDI | Class II | Active |
| Orthros | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 30mm Lg. | FDA UDI | Class II | Active |
| Orthros MIS | ORM-85105L | FDA UDI | Class II | Active |
| Orthros Mis | ORM-1-7525L | FDA UDI | Class II | Active |
| SPIRA®-P Integrated Fixation System | SPP-2210-1517 | FDA UDI | Class II | Active |
| Variant Retractor | SPO-115-713 | FDA UDI | Class I | Active |
| Tls 5.0 | CK-221209 | FDA UDI | Class II | Active |
| SPIRA®-T Integrated Fixation System | SPT-3009-0715 | FDA UDI | Class II | Active |
| SPIRA®-L Open Matrix LLIF | SPL-1860-1514 | FDA UDI | Class II | Active |
| Spira-C | SPC-102-026 | FDA UDI | Class I | Active |
| Variant | SPO-115-212 | FDA UDI | Class I | Active |
| SPIRA®-T Integrated Fixation System | SPT-3009-1515 | FDA UDI | Class II | Active |
| MIS Disc Prep | MDP-108-003 | FDA UDI | Class I | Active |
| Orthros | CP-009-53 | FDA UDI | Class II | Active |
| Navigation Instrument | ORM-NAV-7501 | FDA UDI | Class II | Active |
| Siconus™ SI Joint Fixation System | SCL-11-050 | FDA UDI | Class II | Active |
| SPIRA®-A Integrated | SAZ-2838-1517 | FDA UDI | Class II | Active |
| Diagon | 8°, 10mm x 41mm x 11mm Oblique ASM | FDA UDI | Class II | Active |
| Diagon | 8°, 10mm x 34mm x 9mm Oblique ASM | FDA UDI | Class II | Active |
| Enza | CB-001-031 | FDA UDI | Class II | Active |
| Orthros | ORT-8585R | FDA UDI | Class II | Active |
| Orthros | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 90mm Lg. | FDA UDI | Class II | Active |
| Orthros | CC-117-60 | FDA UDI | Class I | Active |
| Orthros | Ø8.5mm Monoaxial Pedicle Screw, 75mm Lg. | FDA UDI | Class II | Active |
| Orthros Mis | ORM-1-7570 | FDA UDI | Class II | Active |
| Spira-L | SPL-504-003 | FDA UDI | Class I | Active |
| SPIRA®-T Integrated Fixation System | SPT-3011-0708 | FDA UDI | Class II | Active |
| Orthros | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg. | FDA UDI | Class II | Active |
| Orthros Mis | CM-500-02-03 | FDA UDI | Class I | Active |
| TLS 5.0 Interbody Cage | CK-221015 | FDA UDI | Class II | Active |
| SPIRA®-L Open Matrix LLIF | SPL-2250-0012 | FDA UDI | Class II | Active |
| SPIRA®-T Integrated Fixation System | SPT-2609-1513 | FDA UDI | Class II | Active |
| ENZA™-A Titanium ALIF | EZA-2632-0901 | FDA UDI | Class II | Active |
| Orthros Mis | ORM-1-85110L | FDA UDI | Class II | Active |
| ALTIVO Anterior Cervical Fixation System | FCP-2539E | FDA UDI | Class II | Unknown |
| SPIRA®-L Open Matrix LLIF | SPL-1845-0014 | FDA UDI | Class II | Unknown |
| SPIRA®-P Integrated Fixation System | SPP-2810-0714 | FDA UDI | Class II | Active |
| SPIRA®-L Open Matrix LLIF | SPL-1850-1510 | FDA UDI | Class II | Active |
| SPIRA®-A Integrated | SAZ-103-217 | FDA UDI | Class I | Active |
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