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Device
appliance, fixation, spinal intervertebral body
Regulation Description
Spinal intervertebral body fixation orthosis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
KWQ
Premarket Review
Spinal Devices
(DHT6B)
Spinal Devices (DHT6B)
Submission Type
510(k)
Regulation Number
888.3060
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
Recognized Consensus Standards
8-558 ASTM F3333-20
Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
11-276 ASTM F1798-13
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
11-369 ASTM F3292-19
Standard Practice for Inspection of Spinal Implants Undergoing Testing
11-375 ASTM F2193-20
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
11-388 ASTM F1717-21
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
11-402 ASTM F1798-21
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Guidance Document
Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff
Third Party Review
Not Third Party Eligible
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