Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K200367
Distal Humerus Plating System · Skeletal Dynamics, Inc. · decided 2020-05-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Humeral Plating System | Distal Trochlea Compression Screw, 3.5mm x 65mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506115665 |
| Humeral Plating System | Midshaft Humerus Plate, Broad 172mm | SKELETAL DYNAMICS L.L.C. | HRS | 00841506111483 |
| Humeral Fixation Set | FreeFix™, Distal Humerus Plate, Lateral Capitellar, 7 Hole, Left | SKELETAL DYNAMICS L.L.C. | HRS | 00841506129402 |
| Humeral Fixation Set | FreeFix™, Distal Humerus Plate, Lateral Helical, 3 Hole, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506129273 |
| Humeral Fixation Set | FreeFix™, Distal Humerus Plate, Medial Direct, 5 Hole, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506129174 |
| Humeral Fixation Set | Screw, Polyaxial Locking, 3.0mm x 55mm Cannulated, CoCr | SKELETAL DYNAMICS L.L.C. | HRS | 00841506117782 |
| Humeral Fixation Set | TiBeam™, Trochlea Compression Screw, Male, 60mm | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110417 |
| Humeral Plating System | Distal Humerus Plate, Lateral Capitellur, 100mm, Left | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110219 |
| Humeral Plating System | Screw, Multi-Thread, Compression, 2.7mm x 26mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110820 |
| Humeral Fixation Set | Humeral Fixation System B | SKELETAL DYNAMICS L.L.C. | HRS | 00841506134888 |
| Humeral Fixation Set | FreeFix™, Distal Humerus Plate, Lateral Capitellar, 9 Hole, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506129419 |
| Humeral Fixation Set | Screw, Multi-Thread, Locking, 2.7mm x 36mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110646 |
| Humeral Fixation Set | FreeFix™, Distal Humerus Plate, Lateral Capitellar, 5 Hole, Left | SKELETAL DYNAMICS L.L.C. | HRS | 00841506129389 |
| Humeral Plating System | Screw, Locking, FreeFix, 4.5mm x 28mm, Ti | SKELETAL DYNAMICS L.L.C. | HWC | 00841506111209 |
| Humeral Fixation Set | Screw, Multi-Thread, Locking, 2.7mm x 40mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110660 |
| Humeral Plating System | Distal Humerus Plate, Lateral Helical, 85mm, Left | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110035 |
| Humeral Fixation Set | K-Wire, Standard Diamond Tip with Stop, 2.0 mm x 152 mm | SKELETAL DYNAMICS L.L.C. | HRS | 00841506117836 |
| Humeral Fixation Set | Screw, FreeFix™ Locking, 3.5mm x 32mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506130156 |
| Humeral Plating System | Distal Trochlea Compression Screw, 3.5mm x 75mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506115689 |
| Humeral Fixation Set | Screw, Polyaxial Locking, 3.0mm x 12mm Cannulated, CoCr | SKELETAL DYNAMICS L.L.C. | HRS | 00841506127798 |
| Humeral Plating System | Screw, Polyaxial Locking, 3.0mm x 58mm Cannulated, CoCr | SKELETAL DYNAMICS L.L.C. | HRS | 00841506111063 |
| Humeral Plating System | Distal Humerus Plate, Supracondylar, 250mm, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110301 |
| Humeral Plating System | Distal Humerus Plate, Lateral Capitellur, 160mm, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506110240 |
| Humeral Fixation Set | FreeFix™, Distal Humerus Plate, Lateral Direct, 3 Hole, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506129235 |
| Humeral Plating System | Screw, Compression, 4.5mm x 32mm, Ti | SKELETAL DYNAMICS L.L.C. | HWC | 00841506111391 |