Alpine Cemented Hip System
FDA 510(k) K153216 · Ortho Development Corporation
510(k) numberK153216
Submission
- Device name
- Alpine Cemented Hip System
- Applicant
- Ortho Development Corporation
Draper, UT, US - Received
- November 5, 2015
- Decision date
- February 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K242833 | Legend® Acetabular ShellLPH · Special | 10/11/2024SE |
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| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
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| K200281 | The Gecko Spinal SystemOWI · Traditional | 03/31/2020SE |
Questions and answers
When was Alpine Cemented Hip System cleared by the FDA?
Alpine Cemented Hip System (K153216) received a 510(k) decision of Substantially Equivalent on February 18, 2016, 105 days after the submission was received.
What is the product code of K153216?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.