← Product Code [HBL](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL) · K002276

# PSI SKULL CLAMP (K002276)

_V. Mueller Neuro/Spine · HBL · Aug 29, 2000 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K002276

## Device Facts

- **Applicant:** V. Mueller Neuro/Spine
- **Product Code:** [HBL](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL.md)
- **Decision Date:** Aug 29, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4460
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K002276](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K002276)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
