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Sign in to claim this brandISOTIS ORTHOBIOLOGICS, INC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2 Goodyear, IRVINE, CA, 92618
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3001503333
- DUNS Number
- —
Catalogue (111)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OsteoStrux Putty | 56070050 | FDA UDI | Class II | Active |
| OsteoBallast | 56800060 | FDA UDI | Class II | Active |
| Current | 02-9000-100 | FDA UDI | Class II | Active |
| OsteoSurge 100 Putty | 56300100 | FDA UDI | Class II | Active |
| OsteoStrux Putty | 56070025 | FDA UDI | Class II | Active |
| Dynagraft II Putty | 02-2010-100 | FDA UDI | Class II | Active |
| OsteoSurge 100 Putty | 56300025 | FDA UDI | Class II | Active |
| OsteoSurge 100 Putty | 56300010 | FDA UDI | Class II | Active |
| IsoTis Mozaik Moldable Morsels | MSL075 | FDA UDI | Class II | Active |
| Ballast | 02-8000-095 | FDA UDI | Class II | Active |
| OsteoSparx Putty | 56210100 | FDA UDI | Class II | Active |
| Arthrex | ABS-2014-05 | FDA UDI | Class II | Active |
| Current | 02-9000-050 | FDA UDI | Class II | Active |
| OsteoSurge 300C Putty | 56510050 | FDA UDI | Class II | Active |
| IsoTis Mozaik Putty | PTY10256 | FDA UDI | Class II | Active |
| Accell Connexus | 02-3000-050 | FDA UDI | Class II | Active |
| Accell Connexus | 02-3000-010 | FDA UDI | Class II | Active |
| Orthoblast II Paste | 02-2100-005 | FDA UDI | Class II | Active |
| Dynagraft II Putty | 02-2010-010 | FDA UDI | Class II | Active |
| Ballast | 02-8000-060 | FDA UDI | Class II | Active |
| IsoTis Mozaik Strip | CCM10210 | FDA UDI | Class II | Active |
| OsteoSparx Gel | 56200050 | FDA UDI | Class II | Active |
| Dynagraft II Putty | 02-2010-025 | FDA UDI | Class II | Active |
| OsteoSparx C Putty | 56230100 | FDA UDI | Class II | Active |
| OsteoSurge 300 Putty | 56500100 | FDA UDI | Class II | Active |
| IsoTis Mozaik Moldable Morsels | MSL150 | FDA UDI | Class II | Active |
| OsteoSparx C Paste | 56220030 | FDA UDI | Class II | Active |
| OsteoSurge 100 Putty | 56300050 | FDA UDI | Class II | Active |
| Accell Evo3 Putty | 02-5000-050 | FDA UDI | Class II | Active |
| OsteoCurrent | 56900010 | FDA UDI | Class II | Active |
| OsteoSparx Gel | 56200100 | FDA UDI | Class II | Active |
| OsteoBallast | 56800115 | FDA UDI | Class II | Active |
| IsoTis Mozaik Putty | PTY10155 | FDA UDI | Class II | Active |
| OsteoBallast | 56110000 | FDA UDI | Class II | Active |
| Orthoblast II Paste | 02-2100-010 | FDA UDI | Class II | Active |
| OsteoSparx C Putty | 56230050 | FDA UDI | Class II | Active |
| Orthoblast II Putty | 02-2110-100 | FDA UDI | Class II | Active |
| OsteoSparx Putty | 56210025 | FDA UDI | Class II | Active |
| Arthrex | ABS-2013-05 | FDA UDI | Class II | Active |
| OsteoSparx Gel | 56200010 | FDA UDI | Class II | Active |
| Accell Evo3 Putty | 02-5000-100 | FDA UDI | Class II | Active |
| Ballast | 02-1000-000 | FDA UDI | Class II | Active |
| IsoTis Mozaik Putty | PTY10210 | FDA UDI | Class II | Active |
| OsteoStrux Putty | 56070150 | FDA UDI | Class II | Active |
| Arthrex | ABS-2015-01 | FDA UDI | Class II | Active |
| Accell TBM | 02-4000-520 | FDA UDI | Class II | Active |
| Dynagraft II Gel | 02-2000-010 | FDA UDI | Class II | Active |
| OsteoSparx C Paste | 56220080 | FDA UDI | Class II | Active |
| Orthoblast II Putty | 02-2110-050 | FDA UDI | Class II | Active |
| Arthrex | ABS-2015-03 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 27, 2024 | Z-0919-2025 | — | open, classified | Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. |
| Nov 27, 2024 | Z-0955-2025 | — | open, classified | Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray. |