The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Ti-frame.
Device ID | K934860 |
510k Number | K934860 |
Device Name: | TI-FRAME |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 41 PACELLA PARK DR. RANDOLPH IND. PARK Randolph, MA 02368 |
Contact | Amy Walters |
Correspondent | Amy Walters JOHNSON & JOHNSON PROFESSIONALS, INC. 41 PACELLA PARK DR. RANDOLPH IND. PARK Randolph, MA 02368 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-12 |
Decision Date | 1994-06-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TI-FRAME 78724587 3138960 Dead/Cancelled |
Johnson & Johnson 2005-09-30 |
![]() TI-FRAME 75369288 2179770 Live/Registered |
Johnson & Johnson 1997-10-07 |
![]() TI-FRAME 74657193 not registered Dead/Abandoned |
JOHNSON & JOHNSON 1995-03-17 |