TENO FIX
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
ORTHEON MEDICAL, LLC.
The following data is part of a premarket notification filed by Ortheon Medical, Llc. with the FDA for Teno Fix.
Pre-market Notification Details
| Device ID | K023594 |
| 510k Number | K023594 |
| Device Name: | TENO FIX |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | ORTHEON MEDICAL, LLC. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ORTHEON MEDICAL, LLC. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-25 |
| Decision Date | 2003-05-15 |
| Summary: | summary |
Trademark Results [TENO FIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENO FIX 76419907 2763719 Live/Registered |
TENDON TECHNOLOGY, LTD. 2002-06-13 |
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