510(k) K080083 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
INTREPID SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Apr 10, 2008 |
| Received | Jan 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STE Terminated |
MAX | None listed |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, ST Terminated |
MAX | None listed |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only Terminated |
MAX | None listed |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx on Terminated |
MAX | None listed |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx onl Terminated |
MAX | None listed |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF 7963210; 12MM, REF 7963212, 14MM, REF 7963214; 16MM, REF 7963216; 18MM, REF 7963218; 20MM, REF 7963220; USA, Rx on Terminated |
MAX | None listed |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330; medium, REF 7962330; large, REF 7963330; STERILE R.
The INTREPID Spinal System is indicated for use with autogenou Terminated |
MAX | None listed |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx o Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.