Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K100516
ANYPLUS PEEK CAGES · GS Medical Co., Ltd. · decided 2010-12-03 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Pulsar Expandable PLIF System | 2212-1011 | GS Medical Co., Ltd. | MAX | 08809974815861 |
| PYXIS 3D Titanium Cage System | 8054-0855S | GS Medical Co., Ltd. | MAX | 08809885764647 |
| AnyPlus PEEK Lumbar Cages | 1101-0015 | GS Medical Co., Ltd. | MAX | 08806378361734 |
| AnyPlus PEEK Lumbar Cages | 1103-1012 | GS Medical Co., Ltd. | MAX | 08806162105629 |
| QUASAR Standalone ACIF System | GS136-0200 | GS Medical Co., Ltd. | HTW MAX | 08809885799809 |
| AnyPlus PEEK Lumbar Cages | 1103-7111 | GS Medical Co., Ltd. | MAX | 08806162105063 |
| Anyplus II Spinal Fixation System | GS120-2300 | GS Medical Co., Ltd. | HXX MAX | 08800104097959 |
| PYXIS 3D Titanium Cage System | GS132-6614 | GS Medical Co., Ltd. | LXH MAX | 08809885712983 |
| AnyPlus PEEK Lumbar Cages | 1104-0707 | GS Medical Co., Ltd. | MAX | 08806378362762 |
| AnyPlus PEEK Lumbar Cages | 1104-1716 | GS Medical Co., Ltd. | MAX | 08806162106138 |
| Anyplus II Spinal Fixation System | 2520-5550 | GS Medical Co., Ltd. | MAX | 08809974772294 |
| PYXIS 3D Titanium Cage System | GS166-0105 | GS Medical Co., Ltd. | LXH MAX | 08809885719845 |
| AnyPlus PEEK Lumbar Cages | 1141-0011 | GS Medical Co., Ltd. | MAX | 08806378361925 |
| AnyPlus PEEK Lumbar Cages | 1104-1712 | GS Medical Co., Ltd. | MAX | 08806162106091 |
| AnyPlus PEEK Lumbar Cages | 1103-1814 | GS Medical Co., Ltd. | MAX | 08806162105865 |
| AnyPlus PEEK Lumbar Cages | 1101-0416 | GS Medical Co., Ltd. | MAX | 08806378361819 |
| AnyPlus® Cervical PEEK Cage System | GS138-5234 | GS Medical Co., Ltd. | HTR MAX | 08800104077395 |
| PYXIS 3D Titanium Cage System | GS166-0109 | GS Medical Co., Ltd. | LXH MAX | 08809885719883 |
| AnyPlus PEEK Lumbar Cages | 1141-0415 | GS Medical Co., Ltd. | MAX | 08806378362038 |
| AnyPlus PEEK Lumbar Cages | 1103-1110 | GS Medical Co., Ltd. | MAX | 08806162105933 |
| PYXIS 3D Titanium Cage System | GS166-0109P | GS Medical Co., Ltd. | LXH MAX | 08809974789513 |
| PYXIS 3D Titanium Cage System | GS132-3212 | GS Medical Co., Ltd. | LXH MAX | 08809885712327 |
| AnyPlus PEEK Lumbar Cages | 1103-9415 | GS Medical Co., Ltd. | MAX | 08806162105322 |
| AnyPlus PEEK Lumbar Cages | 1103-7014 | GS Medical Co., Ltd. | MAX | 08806162104981 |
| AnyPlus PEEK Lumbar Cages | 1161-0409 | GS Medical Co., Ltd. | MAX | 08806162104684 |