510(k) K041389 ยท MQP Spinal Vertebral Body Replacement Device
SYNTHES CONTOURED SYNMESH SPACER
| Applicant | Synthes Spine, West Chester PA, US |
| Decision | Substantially Equivalent, Oct 1, 2004 |
| Received | May 25, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041389
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2020 | Synthes (USA) Products LLC 3.0MM LOCKING SCREW LOW PROFILE (TI)
Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprin Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.