Stryker Oral Max System
FDA 510(k) K954690 · Stryker Corp.
510(k) numberK954690
Submission
- Device name
- Stryker Oral Max System
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- October 11, 1995
- Decision date
- August 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
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| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
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Questions and answers
When was Stryker Oral Max System cleared by the FDA?
Stryker Oral Max System (K954690) received a 510(k) decision of Substantially Equivalent on August 20, 1996, 314 days after the submission was received.
What is the product code of K954690?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.