510(k) K252251
- Device
- EASYMADE-TI
- Applicant
- CG Bio Co., Ltd.
- 510(k) number
- K252251
- Product code
- GXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-09
- Date received
- 2025-07-18
- Regulation
- 882.5330
- Classification name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Youngwook Moon
- Address
- 3rd Floor, Hannam Bd. 211, Itaewon-Ro, Yongsan-Gu Seoul KR 04349 04349
FDA Registration Numbers
- 3011423165
- 3009424796
- 2916714
- 3008868758
- 3009582362
- 1825034
- 3007923096
- 3039103971
- 1057946
- 3015531529
- 9610905
- 3010047454
- 3015399803
- 3014279513
- 3004049923
- 3015212339
- 1649518
- 3027157194
- 3015869493
- 9612501
- 3021635140
- 3010407203
- 3008711893
- 3006017180
- 3007738812
- 3015259858
- 9610612
- 3009417901
- 8043792
- 3014680740
- 2011171
- 3000270450
- 2027754
- 3010363503
- 3006130229
- 1032347
- 3014937101
- 3018094310
- 1218882
- 2029275
- 3014483751
- 2029447
- 3008812560
- 3009196021
- 1064858
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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