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Galaxy Mis Screw System
BM KOREA CO., LTD · Model GXMS-6535 · UDI-DI 08809255540109
1
510(k) clearances
3,989
Adverse events (17 deaths)
213
Recalls
343
Facilities
Description
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | XTANT Medical Holdings, Inc | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2018-07-05 | CTL Medical Corporation | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.