510(k) K250989
- Device
- Stryker and Serf hip devices
- Applicant
- Howmedica Osteonics Corp (Dba Stryker Orthopaedics)
- 510(k) number
- K250989
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-25
- Date received
- 2025-03-31
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- 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
- Gregg Ritter
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers
- 1423662
- 1450662
- 1833506
- 3002807090
- 3027484613
- 3004641308
- 2242737
- 3005180920
- 3000236920
- 2133928
- 3007913880
- 1000547811
- 3009241418
- 3006085220
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- 3033509898
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- 1722511
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- 3012130008
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- 9613369
- 3009959868
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- 3012425419
- 3014302784
- 1529009
- 3008262872
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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