← Product Code [HBW](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW) · K001353

# MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM (K001353)

_Biomedical Ent., Inc. · HBW · Mar 13, 2001 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K001353

## Device Facts

- **Applicant:** Biomedical Ent., Inc.
- **Product Code:** [HBW](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW.md)
- **Decision Date:** Mar 13, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5360
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K001353](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K001353)

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