Clearance Summary
RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS received FDA 510(k) clearance under submission number K091041, sponsored by Depuy Mitek, A Johnson & Johnson Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-08-07.
- Submission: K091041
- Applicant / Sponsor: Depuy Mitek, A Johnson & Johnson Company
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2009-08-07
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.