Clearance Summary
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) received FDA 510(k) clearance under submission number K852397, sponsored by Howmedica Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1985-08-09.
- Submission: K852397
- Applicant / Sponsor: Howmedica Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1985-08-09
Classification & Regulation
This clearance is catalogued under FDA product code JEC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.