Kelyniam Global, Inc.
Kelyniam Global, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2025, with 4 FDA device recalls on record.
Top product codes for Kelyniam Global, Inc.
FDA recalls by Kelyniam Global, Inc.
- Z-1873-2018 — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
- Z-1871-2018 — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
- Z-1872-2018 — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
- Z-1870-2018 — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Kelyniam Global, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.