K252251
Substantially EquivalentEASYMADE-TI
EASYMADE-TI is an orthopedic or spinal implant — product code GXN is assigned to the Neurology panel but covers fusion cages, spacers, and related spinal hardware. The "TI" suffix indicates titanium construction, a standard choice for load-bearing implants.
Neurology panel (for spine-related hardware), Traditional 510(k). GXN is one of the higher-volume spine codes with a well-characterized predicate set — clearances turn on dimensional, material, and surface-treatment comparisons against prior devices.
CG Bio Co., Ltd. files from Seoul. Nine-month review clock. Korean spine-hardware applicants are a substantial share of GXN filings — several Korean mid-market companies have built their US business on this product code.
- Applicant
- CG Bio Co., Ltd.
- Product code
- GXN
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Adverse events under product code GXN
product code GXN- Injury
- 208
- Total
- 208
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.