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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
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- EUDAMED SRN
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- FDA FEI Number
- 3001503333
- DUNS Number
- —
Catalogue (111)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orthoblast II Paste | 02-2100-080 | FDA UDI | Class II | Active |
| Dynagraft II Gel | 02-2000-005 | FDA UDI | Class II | Active |
| OsteoBallast | 56100000 | FDA UDI | Class II | Active |
| OsteoSparx Putty | 56210010 | FDA UDI | Class II | Active |
| Accell Evo3 C Putty | 02-6000-050 | FDA UDI | Class II | Active |
| OsteoSurge 300C Putty | 56510100 | FDA UDI | Class II | Active |
| IsoTis Mozaik Putty | PTY10125 | FDA UDI | Class II | Active |
| OsteoCurrent | 56900025 | FDA UDI | Class II | Active |
| OsteoStrux Strip | 56010050 | FDA UDI | Class II | Active |
| Accell TBM | 02-4000-760 | FDA UDI | Class II | Active |
| Arthrex | ABS-2015-08 | FDA UDI | Class II | Active |
| IsoTis Mozaik Strip | CCM10155 | FDA UDI | Class II | Active |
| OsteoSurge 300 Putty | 56500025 | FDA UDI | Class II | Active |
| Accell Connexus | 02-3000-005 | FDA UDI | Class II | Active |
| OsteoSurge 300C Putty | 56510025 | FDA UDI | Class II | Active |
| Accell Evo3 C Putty | 02-6000-100 | FDA UDI | Class II | Active |
| Ballast | 02-1100-000 | FDA UDI | Class II | Active |
| Arthrex | ABS-2013-01 | FDA UDI | Class II | Active |
| Arthrex | ABS-2012-01 | FDA UDI | Class II | Active |
| Orthoblast II Paste | 02-2100-030 | FDA UDI | Class II | Active |
| OsteoCurrent | 56900100 | FDA UDI | Class II | Active |
| Ballast | 02-8000-115 | FDA UDI | Class II | Active |
| OsteoCurrent | 56900050 | FDA UDI | Class II | Active |
| Accell TBM | 02-4000-550 | FDA UDI | Class II | Active |
| Dynagraft II Gel | 02-2000-100 | FDA UDI | Class II | Active |
| Accell Evo3 C Putty | 02-6000-025 | FDA UDI | Class II | Active |
| OsteoStrux Strip | 56010100 | FDA UDI | Class II | Active |
| OsteoSurge 300 Putty | 56500050 | FDA UDI | Class II | Active |
| Arthrex | ABS-2014-10 | FDA UDI | Class II | Active |
| Arthrex | ABS-2012-05 | FDA UDI | Class II | Active |
| OsteoSurge 300 Putty | 56500010 | FDA UDI | Class II | Active |
| Accell Connexus | 02-3000-025 | FDA UDI | Class II | Active |
| OsteoBallast | 56800095 | FDA UDI | Class II | Active |
| IsoTis Mozaik Moldable Morsels | MSL015 | FDA UDI | Class II | Active |
| Current | 02-9000-010 | FDA UDI | Class II | Active |
| Arthrex | ABS-2012-02 | FDA UDI | Class II | Active |
| OsteoBallast | 56800180 | FDA UDI | Class II | Active |
| OsteoSparx Putty | 56210050 | FDA UDI | Class II | Active |
| Accell Connexus | 02-3000-100 | FDA UDI | Class II | Active |
| Dynagraft II Gel | 02-2000-050 | FDA UDI | Class II | Active |
| IsoTis Mozaik Moldable Morsels | MSL030 | FDA UDI | Class II | Active |
| Arthrex | ABS-2013-10 | FDA UDI | Class II | Active |
| Dynagraft II Putty | 02-2010-050 | FDA UDI | Class II | Active |
| OsteoSparx C Paste | 56220010 | FDA UDI | Class II | Active |
| IsoTis Mozaik Strip | CCM10256 | FDA UDI | Class II | Active |
| Accell Evo3 Putty | 02-5000-025 | FDA UDI | Class II | Active |
| Current | 02-9000-025 | FDA UDI | Class II | Active |
| OsteoStrux Putty | 56070100 | FDA UDI | Class II | Active |
| Arthrex | ABS-2012-10 | FDA UDI | Class II | Active |
| OsteoStrux Strip | 56010150 | FDA UDI | Class II | Active |
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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. |