510(k) K103582 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
| Applicant | Kelyniam Global, Inc., New Britain CT, US |
| Decision | Substantially Equivalent, Apr 14, 2011 |
| Received | Dec 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) Terminated |
GXN | None listed |
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 Terminated |
GXN | None listed |
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 Terminated |
GXN | None listed |
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 Terminated |
GXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.