restor3d Pin Implants
FDA 510(k) K211789 · Restor3D
510(k) numberK211789
Submission
- Device name
- restor3d Pin Implants
- Applicant
- Restor3D
Durham, NC, US - Received
- June 10, 2021
- Decision date
- January 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was restor3d Pin Implants cleared by the FDA?
restor3d Pin Implants (K211789) received a 510(k) decision of Substantially Equivalent on January 4, 2022, 208 days after the submission was received.
What is the product code of K211789?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.