Clearance Summary
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL received FDA 510(k) clearance under submission number K112663, sponsored by Enhatch Orthopaedics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-03-12.
- Submission: K112663
- Applicant / Sponsor: Enhatch Orthopaedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2012-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.