Clearance Summary
S & S ORTHOPEDIC WIRE DRIVER 701 received FDA 510(k) clearance under submission number K944488, sponsored by S & S Orthopedic , Ltd.. 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 1995-03-02.
- Submission: K944488
- Applicant / Sponsor: S & S Orthopedic , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1995-03-02
Classification & Regulation
This clearance is catalogued under FDA product code KIJ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.