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Device
orthosis, spinal pedicle fixation
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
MNI
Premarket Review
Spinal Devices
(DHT6B)
Spinal Devices (DHT6B)
Submission Type
510(k)
Regulation Number
888.3070
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
8-195 ASTM F2024-10 (Reapproved 2016)
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
8-475 ASTM F2026-17
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
8-574 ASTM F2820-12(2021)e1
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
8-577 ISO 13179-1 Second Edition 2021-09
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
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
11-388 ASTM F1717-21
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Third Party Review
Not Third Party Eligible
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