Regulation Text
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.
Related Guidelines (5)
Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 (Status: Final)
→Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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