The following data is part of a premarket notification filed by Biomedical Enterprises, Inc with the FDA for Speed Shift.
| Device ID | K124022 |
| 510k Number | K124022 |
| Device Name: | SPEED SHIFT |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio, TX 78245 |
| Contact | Joe Soward |
| Correspondent | Joe Soward BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio, TX 78245 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-05-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPEED SHIFT 98641244 not registered Live/Pending |
Lubrication Specialties, LLC 2024-07-10 |
![]() SPEED SHIFT 85427472 4160437 Live/Registered |
Reliable Diamond Tool, Inc. 2011-09-20 |
![]() SPEED SHIFT 76361484 2801780 Live/Registered |
Lifetime Products, Inc. 2002-01-22 |
![]() SPEED SHIFT 75425830 not registered Dead/Abandoned |
Lifetime Products, Inc. 1998-01-29 |
![]() SPEED SHIFT 75420200 2498603 Live/Registered |
INTIME SOLUTIONS INC. 1998-01-20 |
![]() SPEED SHIFT 74489800 not registered Dead/Abandoned |
Coastal Unilube, Inc. 1994-02-14 |