The following data is part of a premarket notification filed by Figure 8 Surgical, Incorporated with the FDA for Figure 8 Sternotomy Closure Device.
| Device ID | K110541 |
| 510k Number | K110541 |
| Device Name: | FIGURE 8 STERNOTOMY CLOSURE DEVICE |
| Classification | Cerclage, Fixation |
| Applicant | FIGURE 8 SURGICAL, INCORPORATED 155-A MOFFETT PARK DRIVE, SUITE 210 Sunnyvale, CA 94089 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan FIGURE 8 SURGICAL, INCORPORATED 155-A MOFFETT PARK DRIVE, SUITE 210 Sunnyvale, CA 94089 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-25 |
| Decision Date | 2011-07-06 |
| Summary: | summary |