Allosource
Centennial, CO, US
ALLOSOURCE appears in FDA device records in Centennial, CO. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Allosource between 2008 and 2023. The busiest year on record is 2008, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2011 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213046 | AceConnex Pre-Sutured Fascia | GAT | Substantially Equivalent | |
| K170957 | ReConnex Pre-Sutured Tendon | GAT | Substantially Equivalent | |
| K103036 | ALLOFUSE PLUS | MQV | Substantially Equivalent | |
| K071849 | ALLOFUSE GEL AND PUTTY | MQV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3000215346 | 3000215346 | ALLOSOURCE | 6278 S Troy Circle, Centennial, CO 80111 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1562-2014 | AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender. | The donor was hemodiluted. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain