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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6278 S Troy Circle, Centennial, CO, 80111
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3000215346
- DUNS Number
- 946808136
Catalogue (47)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AlloFuse® | 90138001 | FDA UDI | Class II | Active |
| AlloFuse® | 90038010 | FDA UDI | Class II | Active |
| AlloFuse® | 90138005 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2002-10 | FDA UDI | Class II | Active |
| ReConnex™ | PST17120 | FDA UDI | Class II | Active |
| AlloFuse® Plus | 90338005 | FDA UDI | Class II | Active |
| AlloFuse® | 90038005 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2001-02 | FDA UDI | Class II | Active |
| AlloFuse® | 90038002 | FDA UDI | Class II | Active |
| ReConnex™ | PST17110 | FDA UDI | Class II | Active |
| AceConnex™ | PSF141140-6 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2004-01 | FDA UDI | Class II | Active |
| AlloFuse® | 90138010 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2002-05 | FDA UDI | Class II | Active |
| AlloFuse® Plus | 90238003 | FDA UDI | Class II | Active |
| ReConnex™ | PST17085 | FDA UDI | Class II | Active |
| AlloFuse® | 90038001 | FDA UDI | Class II | Active |
| AceConnex™ | PSF141060-6 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2001-01 | FDA UDI | Class II | Active |
| ReConnex™ | PST17080 | FDA UDI | Class II | Active |
| ReConnex™ | PST17070 | FDA UDI | Class II | Active |
| AceConnex™ | PSF141060-5 | FDA UDI | Class II | Active |
| AceConnex™ | PSF141140-5 | FDA UDI | Class II | Active |
| AceConnex™ | PSF141100-6 | FDA UDI | Class II | Active |
| ReConnex™ | PST17105 | FDA UDI | Class II | Active |
| ReConnex™ | PST17095 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2002-01 | FDA UDI | Class II | Active |
| ReConnex™ | PST17125 | FDA UDI | Class II | Active |
| ReConnex™ | PST17075 | FDA UDI | Class II | Active |
| ReConnex™ | PST17115 | FDA UDI | Class II | Active |
| AlloFuse® Plus | 90338010 | FDA UDI | Class II | Active |
| AceConnex™ | PSF141100-5 | FDA UDI | Class II | Active |
| AlloFuse® Plus | 90238001 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2003-05 | FDA UDI | Class II | Active |
| AlloFuse® Plus | 90238008 | FDA UDI | Class II | Active |
| ReConnex™ | PST17130 | FDA UDI | Class II | Active |
| ReConnex™ | PST17090 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2004-03 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2001-10 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2001-05 | FDA UDI | Class II | Active |
| ReConnex™ | PST17100 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2003-10 | FDA UDI | Class II | Active |
| Stimublast® | ABS-2004-08 | FDA UDI | Class II | Active |
| Allofuse Gel And Putty | K071849 | FDA 510(k) | Class II | Active |
| AceConnex Pre-Sutured Fascia | K213046 | FDA 510(k) | Class II | Active |
| Allofuse Plus | K103036 | FDA 510(k) | Class II | Active |
| ReConnex Pre-Sutured Tendon | K170957 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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Authorities
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FDA Recalls (1)
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 |
|---|---|---|---|---|
| Mar 25, 2014 | Z-1562-2014 | — | terminated | The donor was hemodiluted. |