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U.S. Department of Health and Human Services

Product Classification
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Device bone cement, posterior screw augmentation
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Definition The device is intended to augment the fixation of screws in a posterior spinal system construct.
Physical State Viscous, polymethylmethacrylate material that set hardens over time.
Technical Method The device is placed within the prepared bone canal for placement of the posterior screw, and can be delivered through the screw cannulation and fenestrations.
Target Area Prepared bone canal in the posterior spine for placement of a screw.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePML
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3027
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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