510(k) K080108 ยท NDN Cement, Bone, Vertebroplasty
CORTOSS BONE AUGMENTATION MATERIAL
| Applicant | Orthovita, Inc., Malver PA, US |
| Decision | Substantially Equivalent, Jun 5, 2009 |
| Received | Jan 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2021 | Stryker Spine Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 Terminated |
NDN | None listed |
| May 18, 2021 | Stryker Spine Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979 Terminated |
NDN | None listed |
| Apr 1, 2020 | Howmedica Osteonics Corp. Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 Terminated |
NDN | None listed |
| Sep 12, 2011 | Orthovita, Inc. Orthovita(R) Cortoss(TM) Delivery Gun
Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material Terminated |
KIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.