Clearance Summary
RESOLUTION(TM) HIP STEM received FDA 510(k) clearance under submission number K933570, sponsored by Wrightmedicaltechnologyinc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1994-03-07.
- Submission: K933570
- Applicant / Sponsor: Wrightmedicaltechnologyinc
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1994-03-07
Classification & Regulation
This clearance is catalogued under FDA product code LJW and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.