Vertebral Technologies, Inc.
Andover, MN, US
Vertebral Technologies, Inc. appears in FDA device records in Andover, MN. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Vertebral Technologies, Inc. between 2008 and 2013. The busiest year on record is 2009, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131540 | INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K110226 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K110045 | INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K102277 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K093675 | INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 | MAX | Substantially Equivalent | |
| K091988 | MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 | MAX | Substantially Equivalent | |
| K080673 | INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1151-2017 | InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus. | Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain