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 |