510(k) K110976 ยท MQV Filler, Bone Void, Calcium Compound
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
| Applicant | Nanotherapeutics, Inc., Alachua FL, US |
| Decision | Substantially Equivalent, May 3, 2011 |
| Received | Apr 7, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2011 | Nanotherapeutics, Inc Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste** Terminated |
MQV | None listed |
| Dec 2, 2011 | Nanotherapeutics, Inc Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.