510(k) K021458 ยท HRS Plate, Fixation, Bone
SYNTHES IN-SITU BENDER/CUTTER
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jul 24, 2002 |
| Received | May 7, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K021458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2010 | Synthes USA (HQ), Inc. Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S. Terminated |
HRS | None listed |
| Jun 1, 2009 | Synthes Spine Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Terminated |
HRS | None listed |
| Jun 1, 2009 | Synthes Spine Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Terminated |
HRS | None listed |
| May 21, 2009 | Synthes Spine In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S
Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the c Terminated |
HRS | None listed |
| May 21, 2009 | Synthes Spine In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S.
Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of th Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.