Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K151004
PULLUP® Adjustable Juxtacortical Fixation Device · Sbm Sciences For Bio Materials · decided 2015-11-17 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| PULLUP | Adjustable juxtacortical fixation device for cortical tunnel = Ø 5 to 10 mm | S.B.M | MBI | 03760154008976 |
| RIGIDLOOP | T Adjustable Cortical System - Standard | S.B.M | MBI | 03760304680175 |
| PULLUP® Fixation Device | 01 | MEDLINE INDUSTRIES, INC. | MBI | B04816104120 |
| PULLUP | Adjustable juxtacortical fixation device for cortical tunnel = Ø 4.5 mm | S.B.M | MBI | 03760154008969 |
| PULLUP | Adjustable cortical fixation device for cortical tunnel = Ø 5 to 10 mm | S.B.M | MBI | 03760154007122 |
| MBlock | Adjustable Loop | S.B.M | MBI | 03760304680137 |
| PULLUP | Adjustable cortical fixation device for cortical tunnel = Ø 4.5 mm | S.B.M | MBI | 03760154007115 |
| RIGIDLOOP | T Adjustable Cortical System - XL | S.B.M | MBI | 03760304680182 |
| SoftLink™ | Titanium Button w/Adjustable UHMWPE Loop - cortical tunnel = Ø 4.5 mm | S.B.M | MBI | 03760154006316 |
| PULLUP® | 16-10412 | MEDLINE INDUSTRIES, INC. | MBI | 00818614020709 |
| RIGIDLOOP Multilig Adjustable Cortical Button | NON STERILE SAMPLE - NOT FOR IMPLANTATION | S.B.M | MBI | 03760304680502 |
| MBlock | Adjustable Loop | S.B.M | MBI | 03760304680151 |
| MBlock | Adjustable Loop XL | S.B.M | MBI | 03760304680168 |
| RIGIDLOOP BTB Adjustable Cortical Button | NON STERILE SAMPLE - NOT FOR IMPLANTATION | S.B.M | MBI | 03760304680519 |
| SoftLink™ | Titanium Button w/Adjustable UHMWPE Loop - cortical tunnel = Ø 5 to 10 mm | S.B.M | MBI | 03760154006323 |
| MBlock | Adjustable Loop XL | S.B.M | MBI | 03760304680144 |