The following data is part of a premarket notification filed by The Straumann Co. with the FDA for Memfix.
| Device ID | K955369 |
| 510k Number | K955369 |
| Device Name: | MEMFIX |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Contact | Carolyn M Bitetti |
| Correspondent | Carolyn M Bitetti THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-24 |
| Decision Date | 1996-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031718259 | K955369 | 000 |
| 07630031718242 | K955369 | 000 |
| 07630031718235 | K955369 | 000 |
| 07630031718228 | K955369 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEMFIX 74202692 1725358 Dead/Cancelled |
STRAUMANN HOLDING AG 1991-09-12 |