Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K111620
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS · Skeletal Dynamics, LLC · decided 2011-08-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Geminus | Screw, Cortical Non Locking, 3.5mm x 13mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506102825 |
| Geminus | Threaded Peg, Locking, 2.3mm x 21mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103433 |
| Geminus | Screw, Cortical Non Locking, 3.5mm x 8mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506102771 |
| Geminus | Smooth Peg, Locking, 2.0mm x 16mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506102979 |
| Geminus | GEMINUS Volar Distal Radius Plate, Standard, 7 Hole, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506101668 |
| Geminus | Threaded Peg, Locking, 2.3mm x 14mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103372 |
| Geminus | Assembled, GEMINUS Volar Distal Radius Plate, Standrard, 125mm, Right | SKELETAL DYNAMICS L.L.C. | HRS | 00841506105659 |
| Geminus | Smooth Peg, Locking, 2.0mm x 26mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103068 |
| Geminus | Smooth Peg, Locking, 2.0mm x 23mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103044 |
| Geminus | Smooth Peg, Locking, 2.0mm x 19mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103006 |
| Geminus | GEMINUS Volar Distal Radius Plate, Standard, 3 Hole, Left | SKELETAL DYNAMICS L.L.C. | HRS | 00841506101583 |
| Geminus | High Compression Locking Peg, 2.7mm x 14mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506101705 |
| Geminus | Threaded Peg, Non-Locking, 2.7mm x 32mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103624 |
| Geminus | Threaded Peg, Locking, 2.3mm x 23mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103457 |
| Geminus | Smooth Peg, Locking, 2.0mm x 21mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103020 |
| Geminus | Handle, Small QC, Fixed | SKELETAL DYNAMICS L.L.C. | HRS | 00841506102078 |
| Geminus | GEMINUS Plate Bender | SKELETAL DYNAMICS L.L.C. | HRS | 00841506101484 |
| Geminus | Instrument, Key Periosteal Elevator, Standard | SKELETAL DYNAMICS L.L.C. | HRS | 00841506102450 |
| Geminus | High Compression Locking Peg, 2.7mm x 16mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506101712 |
| Geminus | Threaded Peg, Non-Locking, 2.7mm x 24mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103587 |
| Geminus | Threaded Peg, Non-Locking, 2.7mm x 20mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103563 |
| Geminus | Threaded Peg, Locking, 2.3mm x 22mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103440 |
| Geminus | Threaded Peg, Locking, 2.3mm x 24mm, Ti | SKELETAL DYNAMICS L.L.C. | HRS | 00841506103464 |
| Geminus | K-Wire, Standard Tip, 0.9mm x 152mm | SKELETAL DYNAMICS L.L.C. | HRS | 00841506102498 |
| Geminus | GEMINUS Drill Block, Left, Standard | SKELETAL DYNAMICS L.L.C. | HRS | 00841506101392 |