510(k) K252846
- Device
- TaperSet Hip System
- Applicant
- Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
- 510(k) number
- K252846
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-20
- Date received
- 2025-09-08
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Romil Sheth
- Address
- 1115 Windfield Way El Dorado Hills CA US 95762 95762
FDA Registration Numbers
- 1423662
- 1450662
- 1833506
- 3002807090
- 3027484613
- 3004641308
- 2242737
- 3005180920
- 3000236920
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- 3014302784
- 1529009
- 3008262872
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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