KELYNIAM CUSTOM SKULL IMPLANT (CSI)— 510(k) K103582
Substantially EquivalentKelyniam Global, Inc.
FDA 510(k) clearance K103582 for KELYNIAM CUSTOM SKULL IMPLANT (CSI), Substantially Equivalent on 2011-04-14. Applicant: Kelyniam Global, Inc.. Device class: 2.
Clearance details
- Applicant
- Kelyniam Global, Inc.
- Product code
- Code GXN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Britain, CT, US
Recent devices under product code GXN
view allMore clearances from Kelyniam Global, Inc.
view allAdverse 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 →
Recalls naming K103582
K-number listed on FDA's recall record- Z-1870-2018 — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
- 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-1873-2018 — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103582.
Data sourced from openFDA. This site is unofficial and independent of the FDA.