Clearance Summary
Aesculap T-Space PEEK and XP Spinal System received FDA 510(k) clearance under submission number K151056, sponsored by Aesculap Implant Systems, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-08-13.
- Submission: K151056
- Applicant / Sponsor: Aesculap Implant Systems, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2015-08-13
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.