Clearance Summary
SHORTENING OSTEOTOMY GUIDE received FDA 510(k) clearance under submission number K861576, sponsored by Osteotomy Guide Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1986-05-12.
- Submission: K861576
- Applicant / Sponsor: Osteotomy Guide Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4600
- Decision date: 1986-05-12
Classification & Regulation
This clearance is catalogued under FDA product code HTH and 21 CFR 888.4600, within the Orthopedic review panel as a Class I device.