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 |