Processed by MTF, designed and available through Synthes Spine, these allograft spacers are engineered to meet the specific demands of spinal applications. Multiple heights accommodate individual patient anatomy, eliminating the time-consuming process of intraoperative graft creation.
Key Features & Benefits
- Luminary ALIF Instrument Set offers novel instruments designed to provide quick, clean discectomies and controlled implant insertion for a precise fit without compromising the anatomy
- FRA Spacers are designed to meet the basic needs of ALIF surgery; they feature flat superior and inferior surfaces and demineralized surfaces
- ALIF Spacers are an advancement to FRA Spacers; they feature curved superior and inferior surfaces and anatomical footprint to interface the disc space
- Luminary CC-ALIF Spacers are the most advanced ALIF Spacer offered; they feature convex surfaces and anatomical footprint to match natural endplate geometry and a cancellous center to permit rapid absorbtion of blood into the implant
Indications
- Anterior Lumbar Interbody Fusion
Notes:
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The FDA regulates donated human tissue under FDA regulation 21 CFR Part 1270, Human Tissue Intended for Transplantation and 21 CFR 1271, Human Cell, Tissue, and Cellular and Tissue-Based Product. These regulations outline the requirements for donor screening, infectious disease testing, record keeping, and facility inspections. Facilities, including MTF, that distribute human tissue intended for transplantation are not required to obtain FDA premarket approval (PMA), Investigational Device Exemption (IDE) or 510(k) clearance to distribute human tissues provided the tissue meets the FDA’s definition of human tissues as described in 21 CFR 1270 and 1271
- Instruments are Class I devices
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