Clearance Summary
GSPE Spacer received FDA 510(k) clearance under submission number K260063, sponsored by The General Hospital Corporation, d/b/a Massachusetts. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-09-11.
- Submission: K260063
- Applicant / Sponsor: The General Hospital Corporation, d/b/a Massachusetts
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2026-09-11
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.