510(k) K103136 ยท JEY Plate, Bone
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Mar 18, 2011 |
| Received | Oct 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103136
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2023 | Materialise N.V. ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
Identificatio Completed |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.