S.O.S. Proximal Femur
FDA 510(k) K933281 · Wrightmedicaltechnologyinc
510(k) numberK933281
Submission
- Device name
- S.O.S. Proximal Femur
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- July 6, 1993
- Decision date
- June 7, 1994
- 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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| 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 S.O.S. Proximal Femur cleared by the FDA?
S.O.S. Proximal Femur (K933281) received a 510(k) decision of Substantially Equivalent on June 7, 1994, 336 days after the submission was received.
What is the product code of K933281?
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.