Term #1,790
nonunion
Claim Term
nonunion
Origin matter
BONE FIXATION DEVICES, SYSTEMS, AND METHODS
Reference Case 1
NXT-5
Date Added
7/26/22
Created
7/26/22, 6:05 PM
Modified
7/26/22, 6:05 PM
Full Desc
"Nonunion" refers to a condition of a bone fracture in which the has not healed or shown radiographical signs of healing progression since a minimum of nine months have elapsed since the injury, i.e., no change in the fracture callus, for the final three months (i.e., six months to be considered a nonunion plus three additional months to verify that the nonunion is established). (Food and Drug Administration. "Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices." United Stated: Office of the Federal Register, National Archives and Records Administration (1998). Modified.)
Applications using this term
| Matter | Usage | Notes | Actions |
|---|---|---|---|
| NXT-5PROV NXT-5, 6, 7, 8 | Defined | — | App terms |