TITAN 3-D Wedge System— 510(k) K231496
Substantially EquivalentParagon 28, Inc.
FDA 510(k) clearance K231496 for TITAN 3-D Wedge System, Substantially Equivalent on 2023-08-22. Applicant: Paragon 28, Inc.. Device class: 2.
Clearance details
- Applicant
- Paragon 28, Inc.
- Product code
- Code PLF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
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