510(k) K251052
- Device
- Trivicta® Hip Stem
- Applicant
- Ortho Development Corp.
- 510(k) number
- K251052
- Product code
- MEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-22
- Date received
- 2025-04-03
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Drew Weaver
- Address
- 12187 S. Business Park Dr. Draper UT US 84020 84020
FDA Registration Numbers
- 1450662
- 3000236920
- 2242737
- 3005180920
- 2133928
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- 1000547811
- 3013176080
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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