The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Orthofix.
| Device ID | K831576 |
| 510k Number | K831576 |
| Device Name: | ORTHOFIX |
| Classification | Component, Traction, Invasive |
| Applicant | ELECTRO-BIOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOFIX 85740258 4720572 Live/Registered |
Orthofix Srl 2012-09-27 |
![]() ORTHOFIX 85534194 not registered Dead/Abandoned |
Bonafix Surgical and Dental Implants, LLC 2012-02-05 |
![]() ORTHOFIX 78427227 3004080 Live/Registered |
DYNASTY CONSOLIDATED INDUSTRIES, INC. 2004-05-28 |
![]() ORTHOFIX 75326029 not registered Dead/Abandoned |
Binder Kletten-Haftverschlub-Systeme GmbH 1997-07-17 |
![]() ORTHOFIX 73471468 1310950 Live/Registered |
Orthofix S.r.l. 1984-03-21 |