Spectron Conversion Endoprosthesis Cup
FDA 510(k) K823726 · Richard'S Medical Equip., Inc.
510(k) numberK823726
Submission
- Device name
- Spectron Conversion Endoprosthesis Cup
- Applicant
- Richard'S Medical Equip., Inc.
Mchenry, IL, US - Received
- December 10, 1982
- Decision date
- March 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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More from Theken Companies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K830793 | Patient Guided Elbow & Shoulder ExercBXB · Traditional | 06/16/1983SE |
| K823837 | RMC Total Knee SystemMBV · Traditional | 03/29/1983SE |
| K823724 | Spectron Neck Replacement ProsthesisJDI · Traditional | 03/09/1983SE |
| K823723 | Spectron Proximal Femoral ProsthesisJDI · Traditional | 03/09/1983SE |
| K823727 | Spectron Primary Stem Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K823722 | Spectron Long, Straight Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K830153 | Richards Intra-Articular Shaver BladesGEY · Traditional | 02/28/1983SE |
| K830154 | Colles Fracture FrameJEC · Traditional | 02/02/1983SE |
| K823729 | Spectron Metal Back Acetabular ComponentJDI · Traditional | 01/21/1983SE |
| K823728 | Spectron Polyethylene Acctubular ComponJDI · Traditional | 01/21/1983SE |
Questions and answers
When was Spectron Conversion Endoprosthesis Cup cleared by the FDA?
Spectron Conversion Endoprosthesis Cup (K823726) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 89 days after the submission was received.
What is the product code of K823726?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.