510(k) K051611 ยท HWC Screw, Fixation, Bone
MBARESORB IMPLANT
| Applicant | Kinetikos Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 6, 2005 |
| Received | Jun 17, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 10mm
Catalog Number: 40010 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | None listed |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 11mm
Catalog Number: 040011 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | None listed |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 12mm
Catalog Number: 040012 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.