510(k) K003281 ยท JEY Plate, Bone
LACTOSORB RAPIDFLAP
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 7, 2001 |
| Received | Oct 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2018 | Zimmer Biomet, Inc. Lactosorb RapidFlap, bone plate, Model No. 915-0020
The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation. Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.