510(k) K042514 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
| Applicant | Blackstone Medical, Inc., Springfield MA, US |
| Decision | Substantially Equivalent, Oct 7, 2004 |
| Received | Sep 16, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2009 | Blackstone Medical, Inc. Blackstone Medical:
ICON Modular Pedicle Screw System;
P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants. Terminated |
MNI | None listed |
| Apr 19, 2006 | Blackstone Medical Inc. ICON Modular Spinal Fixation System used with the:
ICON Implant Case (containing Pedicle Screws) Item Number 54-1090
ICON Instrument Case 1 Item Number: 54-1091
ICON Instrument Case 2 Item Number: 54 Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.