Clearance Summary
THE (CROM) TESTER received FDA 510(k) clearance under submission number K870767, sponsored by Twin City Surgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-03-17.
- Submission: K870767
- Applicant / Sponsor: Twin City Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1520
- Decision date: 1987-03-17
Classification & Regulation
This clearance is catalogued under FDA product code KQW and 21 CFR 888.1520, within the Orthopedic review panel as a Class I device.