Restor3d Utility Wedge
FDA 510(k) K201314 · Restor3D, Inc.
510(k) numberK201314
Submission
- Device name
- Restor3d Utility Wedge
- Applicant
- Restor3D, Inc.
Durham, NC, US - Received
- May 18, 2020
- Decision date
- June 17, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLF – Bone Wedge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
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Questions and answers
When was Restor3d Utility Wedge cleared by the FDA?
Restor3d Utility Wedge (K201314) received a 510(k) decision of Substantially Equivalent on June 17, 2021, 395 days after the submission was received.
What is the product code of K201314?
The FDA product code is PLF – Bone Wedge, a Class II (moderate risk) device regulated under 21 CFR 888.3030.