Whiteside Ortholoc Total Hip Femoral
FDA 510(k) K842559 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK842559
Submission
- Device name
- Whiteside Ortholoc Total Hip Femoral
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
P.O. Box 1767 Midland, MI, US - Received
- July 2, 1984
- Decision date
- December 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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More from Osteoremedies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K853186 | Silastic Inflatable Bone Plug H.P.LZN · Traditional | 09/24/1985SE |
| K844637 | Whiteside Acrylic Cement Spacer SleeveLTC · Traditional | 06/19/1985SE |
| K850255 | Dow Corning Wright Titanium Wrist Joint Grommet · Traditional | 05/01/1985SE |
| K843995 | Tf-Ii Hip ProsthesisKWL · Traditional | 04/23/1985SE |
| K840357 | Ssa Hip ProsthesisJDI · Traditional | 02/17/1984SE |
| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | 06/15/1983SE |
| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | 07/10/1981SE |
| K801175 | Silastic II Mammary Implant · Traditional | 12/18/1980SE |
Questions and answers
When was Whiteside Ortholoc Total Hip Femoral cleared by the FDA?
Whiteside Ortholoc Total Hip Femoral (K842559) received a 510(k) decision of Substantially Equivalent on December 20, 1984, 171 days after the submission was received.
What is the product code of K842559?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.