510(k) K102722 ยท MQV Filler, Bone Void, Calcium Compound
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
| Applicant | Synthes USA Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Jan 27, 2011 |
| Received | Sep 21, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102722
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2017 | Synthes USA Norian Drillable Inject Terminated |
OIS | None listed |
| Jun 9, 2016 | Synthes (USA) Products LLC Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S
Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. Terminated |
MQV | None listed |
| Jun 9, 2016 | Synthes (USA) Products LLC Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S
Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure. Terminated |
MQV | None listed |
| Jun 9, 2016 | Synthes (USA) Products LLC Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S
Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure. Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.