The following data is part of a premarket notification filed by Cp Medical with the FDA for Orthofiber.
| Device ID | K041894 |
| 510k Number | K041894 |
| Device Name: | ORTHOFIBER |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | CP MEDICAL 803 N.E. 25TH AVENUE Portland, OR 97232 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt CP MEDICAL 803 N.E. 25TH AVENUE Portland, OR 97232 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-13 |
| Decision Date | 2004-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20790986004713 | K041894 | 000 |
| 20790986004553 | K041894 | 000 |
| 20790986004584 | K041894 | 000 |
| 20790986004591 | K041894 | 000 |
| 20790986004607 | K041894 | 000 |
| 20790986004614 | K041894 | 000 |
| 10790986004624 | K041894 | 000 |
| 20790986004638 | K041894 | 000 |
| 20790986004645 | K041894 | 000 |
| 20790986004652 | K041894 | 000 |
| 20790986004669 | K041894 | 000 |
| 20790986004676 | K041894 | 000 |
| 20790986004683 | K041894 | 000 |
| 20790986004690 | K041894 | 000 |
| 20790986004706 | K041894 | 000 |
| 20790986004546 | K041894 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOFIBER 98848583 not registered Live/Pending |
Poly-Med, Inc. 2024-11-12 |
![]() ORTHOFIBER 86389136 not registered Dead/Abandoned |
Amedica Corporation 2014-09-09 |
![]() ORTHOFIBER 77155549 3359218 Dead/Cancelled |
CP Medical 2007-04-12 |