510(k) K071983 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
| Applicant | Aesculap Implant Systems, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, May 1, 2008 |
| Received | Jul 19, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071983
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2013 | Aesculap, Inc. ProSpace Peek Implant 5 degree x 8.5 x 22 mm
The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.