510(k) K231873
- Device
- DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional
- Applicant
- Depuy Ireland UC
- 510(k) number
- K231873
- Product code
- MEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-19
- Date received
- 2023-06-26
- 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
- Jennifer Hill
- Address
- 3 Main St. Ringaskiddy IE
FDA Registration Numbers
- 1450662
- 3000236920
- 2242737
- 3005180920
- 2133928
- 3007913880
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022-01-07 |