The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Box Peek Vbr System.
| Device ID | K062151 |
| 510k Number | K062151 |
| Device Name: | BOX PEEK VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Contact | Warren M Dansie |
| Correspondent | Warren M Dansie INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-27 |
| Decision Date | 2006-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711LS1000 | K062151 | 000 |
| M71188810220 | K062151 | 000 |
| M71188808250 | K062151 | 000 |
| M71188808220 | K062151 | 000 |
| M71188016250 | K062151 | 000 |
| M71188014250 | K062151 | 000 |
| M71188012250 | K062151 | 000 |
| M71188010250 | K062151 | 000 |
| M71188008250 | K062151 | 000 |
| M71181014220 | K062151 | 000 |
| M71181012220 | K062151 | 000 |
| M71181010220 | K062151 | 000 |
| M71181008220 | K062151 | 000 |
| M71180814220 | K062151 | 000 |
| M71180812220 | K062151 | 000 |
| M71180810220 | K062151 | 000 |
| M71180808220 | K062151 | 000 |
| M71188810250 | K062151 | 000 |
| M71188812220 | K062151 | 000 |
| M71188812250 | K062151 | 000 |
| M711TB1018280 | K062151 | 000 |
| M711TB1016280 | K062151 | 000 |
| M711TB1014280 | K062151 | 000 |
| M711TB1013280 | K062151 | 000 |
| M711TB1012280 | K062151 | 000 |
| M711TB1011280 | K062151 | 000 |
| M711TB1010280 | K062151 | 000 |
| M711TB1009280 | K062151 | 000 |
| M711TB1008280 | K062151 | 000 |
| M711TB1007280 | K062151 | 000 |
| M71190814250 | K062151 | 000 |
| M71190812250 | K062151 | 000 |
| M71190810250 | K062151 | 000 |
| M71190808250 | K062151 | 000 |
| M71188814250 | K062151 | 000 |
| M71188814220 | K062151 | 000 |
| M711LS2870 | K062151 | 000 |