510(k) K811101 ยท LYC Bone Grafting Material, Synthetic
HYDROXYLAPATITE
| Applicant | Carbomedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 20, 1981 |
| Received | Apr 21, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2009 | Zimmer Inc. Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003.
Device is used fo Terminated |
LYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.