TITAN 3-D Wedge System
FDA 510(k) K231496 · Paragon 28, Inc.
510(k) numberK231496
Submission
- Device name
- TITAN 3-D Wedge System
- Applicant
- Paragon 28, Inc.
Englewood, CO, US - Received
- May 24, 2023
- Decision date
- August 22, 2023
- 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 TITAN 3-D Wedge System cleared by the FDA?
TITAN 3-D Wedge System (K231496) received a 510(k) decision of Substantially Equivalent on August 22, 2023, 90 days after the submission was received.
What is the product code of K231496?
The FDA product code is PLF – Bone Wedge, a Class II (moderate risk) device regulated under 21 CFR 888.3030.