Eska Modular Hip System Cemented
FDA 510(k) K030867 · Eska Implants GmbH
510(k) numberK030867
Submission
- Device name
- Eska Modular Hip System Cemented
- Applicant
- Eska Implants GmbH
Bradenton, FL, US - Received
- March 19, 2003
- Decision date
- September 22, 2003
- 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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| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K053557 | Eska-Libur Hip StemLPH · Special | 01/20/2006SE |
Questions and answers
When was Eska Modular Hip System Cemented cleared by the FDA?
Eska Modular Hip System Cemented (K030867) received a 510(k) decision of Substantially Equivalent on September 22, 2003, 187 days after the submission was received.
What is the product code of K030867?
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.