K-FIX
Pin, Fixation, Smooth
NEWDEAL S.A.
The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for K-fix.
Pre-market Notification Details
| Device ID | K022597 |
| 510k Number | K022597 |
| Device Name: | K-FIX |
| Classification | Pin, Fixation, Smooth |
| Applicant | NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-05 |
| Decision Date | 2002-11-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381780357493 | K022597 | 000 |
Trademark Results [K-FIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K-FIX 78078611 2626747 Dead/Cancelled |
NEWDEAL 2001-08-10 |
 K-FIX 77334596 3467082 Dead/Cancelled |
Paradigm Agricultural Consulting, Inc. 2007-11-20 |
 K-FIX 75768474 2426391 Dead/Cancelled |
Paradigm Agricultural Consulting, Inc. 1999-10-30 |
 K-FIX 75120416 not registered Dead/Abandoned |
Kinetikos Medical, Inc. 1996-06-17 |
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