Beta Femoral Hip Stem
FDA 510(k) K945774 · Wrightmedicaltechnologyinc
510(k) numberK945774
Submission
- Device name
- Beta Femoral Hip Stem
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- November 25, 1994
- Decision date
- December 28, 1995
- 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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| 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 |
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Questions and answers
When was Beta Femoral Hip Stem cleared by the FDA?
Beta Femoral Hip Stem (K945774) received a 510(k) decision of Substantially Equivalent on December 28, 1995, 398 days after the submission was received.
What is the product code of K945774?
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.