Monospherical Resurfacing Glenoid Pros
FDA 510(k) K833409 · Howmedica Corp.
510(k) numberK833409
Submission
- Device name
- Monospherical Resurfacing Glenoid Pros
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- September 30, 1983
- Decision date
- November 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
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| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Monospherical Resurfacing Glenoid Pros cleared by the FDA?
Monospherical Resurfacing Glenoid Pros (K833409) received a 510(k) decision of Substantially Equivalent on November 7, 1983, 38 days after the submission was received.
What is the product code of K833409?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.