510(k) K050892 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Blackstone Medical, Inc., Springfield MA, US |
| Decision | Substantially Equivalent, May 11, 2005 |
| Received | Apr 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2010 | Blackstone Medical, Inc. Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070.
Non Sterile. Terminated |
KWQ | None listed |
| Jan 26, 2008 | Blackstone Medical, Inc. Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.