510(k) K081849 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
| Applicant | Blackstone Medical, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Aug 28, 2008 |
| Received | Jun 30, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081849
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2010 | Orthofix, Inc Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case.
Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and withou Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.