Silastic Hemi Wrist Implant H.P. (Rad.)
FDA 510(k) K812053 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK812053
Submission
- Device name
- Silastic Hemi Wrist Implant H.P. (Rad.)
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Mchenry, IL, US - Received
- July 21, 1981
- Decision date
- August 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXE – Prosthesis, Wrist, Hemi-, Ulnar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3810
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KXE
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|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 05/03/2019SE |
| K142569 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 04/03/2015SE |
| K112481 | First Choice Druj System, Partial Head ImplantKXE · Traditional | Ascension Orthopedic | 04/09/2012SE |
| K081025 | IsoelasticuKXE · Traditional | Remi Sciences, Inc. | 11/21/2008SE |
| K082839 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 10/24/2008SE |
| K061146 | Sbi Ulnar Head ImplantKXE · Special | Small Bone Innovations, Inc. | 07/19/2006SE |
| K053119 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 12/07/2005SE |
| K052137 | Ascension MuhKXE · Traditional | Ascension Orthopedics, Inc. | 11/03/2005SE |
| K040497 | Distal Radio-Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 01/26/2005SE |
| K042902 | Herbert Ulnar Head Prosthesis SystemKXE · Traditional | Stuckenbrock Medizintechnik GmbH | 12/27/2004SE |
More from Stuckenbrock Medizintechnik GmbH
| 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 |
| K842559 | Whiteside Ortholoc Total Hip FemoralKWL · Traditional | 12/20/1984SE |
| 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 |
| 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 Silastic Hemi Wrist Implant H.P. (Rad.) cleared by the FDA?
Silastic Hemi Wrist Implant H.P. (Rad.) (K812053) received a 510(k) decision of Substantially Equivalent on August 18, 1981, 28 days after the submission was received.
What is the product code of K812053?
The FDA product code is KXE – Prosthesis, Wrist, Hemi-, Ulnar, a Class II (moderate risk) device regulated under 21 CFR 888.3810.