510(k) K062012 ยท NKB Thoracolumbosacral Pedicle Screw System
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Feb 9, 2007 |
| Received | Jul 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery. Terminated |
NKB | None listed |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery. Terminated |
NKB | None listed |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery. Terminated |
NKB | None listed |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery. Terminated |
NKB | None listed |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery. Terminated |
NKB | None listed |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.