Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Product Classification
FDA Home
Medical Devices
Databases
-
New Search
Back to Search Results
Device
appliance, nail/blade/plate combination, single component
Regulation Description
Single/multiple component metallic bone fixation appliances and accessories.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
KWK
Premarket Review
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3030
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
8-475 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
8-609 ASTM F2026-23
Standard Specification for 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
11-333 ASTM F382-17
Standard Specification and Test Method for Metallic Bone Plates
11-363 ASTM F897-19
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Third Party Review
Not Third Party Eligible
-
-