Kelyniam Global, Inc.
FDA Regulatory Profile
Kelyniam Global, Inc. appears in FDA public data with 4 recalls, 4 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1873-2018, Class II) was initiated on June 10, 2017. Its most recent 510(k) clearance was granted on July 25, 2025.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 4
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1873-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 | June 10, 2017 |
| Z-1871-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 | June 10, 2017 |
| Z-1872-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 | June 10, 2017 |
| Z-1870-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) | June 10, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | July 25, 2025 |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | May 21, 2019 |
| K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) | September 25, 2012 |
| K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) | April 14, 2011 |