510(k) K030197 ยท KWP Appliance, Fixation, Spinal Interlaminal
BLACKSTONE POSTERIOR CERVICAL SYSTEM
| Applicant | Blackstone Medical, Inc., Springfield MA, US |
| Decision | Substantially Equivalent, Jun 12, 2003 |
| Received | Jan 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2010 | Blackstone Medical, Inc. Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA.
Intended to promote fusion of the cervical spin Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.