CORTOSS BONE AUGMENTATION MATERIAL— 510(k) K080108
Substantially EquivalentOrthovita, Inc.
FDA 510(k) clearance K080108 for CORTOSS BONE AUGMENTATION MATERIAL, Substantially Equivalent on 2009-06-05. Applicant: Orthovita, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthovita, Inc.
- Product code
- Code NDN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malver, PA, US
Recent devices under product code NDN
view allMore clearances from Orthovita, Inc.
view allAdverse events under product code NDN
product code NDN- Death
- 24
- Injury
- 407
- Malfunction
- 1,975
- Total
- 2,406
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 K080108
K-number listed on FDA's recall record- Z-2100-2021 — Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
- Z-2101-2021 — Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
- Z-1900-2020 — Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080108.
Data sourced from openFDA. This site is unofficial and independent of the FDA.