510(k) K043355 ยท KWP Appliance, Fixation, Spinal Interlaminal
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
| Applicant | Sintea Biotech, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Dec 17, 2004 |
| Received | Dec 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043355
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.