Clearance Summary
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM received FDA 510(k) clearance under submission number K001353, sponsored by Biomedical Ent., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-03-13.
- Submission: K001353
- Applicant / Sponsor: Biomedical Ent., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5360
- Decision date: 2001-03-13
Classification & Regulation
This clearance is catalogued under FDA product code HBW and 21 CFR 882.5360, within the Neurology review panel as a Class II device.