510(k) K963951 ยท DZE Implant, Endosseous, Root-Form
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
| Applicant | BioHorizons Implant Systems, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Dec 31, 1996 |
| Received | Oct 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963951
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377. Terminated |
DZE | None listed |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only Terminated |
DZE | None listed |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.