510(k) K091382 ยท GXP Methyl Methacrylate For Cranioplasty
KRYPTONITE BONE CEMENT
| Applicant | Doctors Research Group, Inc., Washington DC, US |
| Decision | Unknown, Nov 16, 2009 |
| Received | May 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2012 | Doctor's Research Group, Inc. Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits:
Product Codes:
KRYP-US-Z-05 (5cc Kit)
KRYP-US-Z -10 (10cc Kit)
Product Usage:
Kryptonite Bone Cement is a resinous materi Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.