Memfix
FDA 510(k) K955369 · The Straumann Co.
510(k) numberK955369
Submission
- Device name
- Memfix
- Applicant
- The Straumann Co.
Cambridge, MA, US - Received
- November 24, 1995
- Decision date
- January 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Hager& Meisinger GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K041070 | Straumann Temporary CopingNHA · Traditional | 07/23/2004SE |
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| K040469 | The Straumann Ortho Implant SystemOAT · Traditional | 04/30/2004SE |
| K993862 | Modus Sagittal Split PlateJEY · Traditional | 12/29/1999SE |
| K962023 | Plastic Protection Healing CapsDZE · Traditional | 08/15/1996SE |
| K960634 | Titanium Healing CapsDZE · Traditional | 06/18/1996SE |
| K955281 | Endosseous Dental Implant & AccessoriesDZE · Traditional | 03/15/1996SE |
| K941393 | Iti Angled AbutmentDZE · Traditional | 06/14/1995SE |
| K943720 | Iti Transversal Screwing SystemDZE · Traditional | 03/24/1995SE |
| K931993 | Iti Distance SystemDZE · Traditional | 04/26/1994SE |
Questions and answers
When was Memfix cleared by the FDA?
Memfix (K955369) received a 510(k) decision of Substantially Equivalent on January 23, 1996, 60 days after the submission was received.
What is the product code of K955369?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.