Clearance Summary
FIGURE 8 STERNOTOMY CLOSURE DEVICE received FDA 510(k) clearance under submission number K110541, sponsored by Figure 8 Surgical, Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-07-06.
- Submission: K110541
- Applicant / Sponsor: Figure 8 Surgical, Incorporated
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 2011-07-06
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.