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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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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3001503333
- DUNS Number
- —
Catalogue (111)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ballast | 02-8000-180 | FDA UDI | Class II | Active |
| Dynagraft Ii | K040419 | FDA 510(k) | Class II | Active |
| Accell Tbm-R | K081817 | FDA 510(k) | Class II | Active |
| Orthoblast Ii Dbm Demineralized Bone Matrix Paste And Putty | K070751 | FDA 510(k) | Class II | Active |
| Ossatura Dental | K042706 | FDA 510(k) | Class II | Active |
| Dynagraft Ii Dental | K043573 | FDA 510(k) | Class II | Active |
| Orthoblast Ii Putty And Paste | K050642 | FDA 510(k) | Class II | Active |
| Connexus, .5cc, Model 023000-005 | K052098 | FDA 510(k) | Class II | Active |
| Connexus | K050690 | FDA 510(k) | Class II | Active |
| Aspirex - Bone Marrow Aspirate Kit | K041991 | FDA 510(k) | Class II | Active |
| Accell Evo3c | K091193 | FDA 510(k) | 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. |