Clearance Summary
ORTHOSORB(R) ABSORBABLE PIN received FDA 510(k) clearance under submission number K901456, sponsored by Johnson & Johnson International. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-08-15.
- Submission: K901456
- Applicant / Sponsor: Johnson & Johnson International
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1990-08-15
Classification & Regulation
This clearance is catalogued under FDA product code OVZ and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.