Clearance Summary
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX received FDA 510(k) clearance under submission number K093864, sponsored by Stryker Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-03-11.
- Submission: K093864
- Applicant / Sponsor: Stryker Corp.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2010-03-11
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.