Clearance Summary
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR received FDA 510(k) clearance under submission number K932595, sponsored by Johnson & Johnson Orthopaedics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1994-09-20.
- Submission: K932595
- Applicant / Sponsor: Johnson & Johnson Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 1994-09-20
Classification & Regulation
This clearance is catalogued under FDA product code LZN and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.