← Product Code [IOZ](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOZ) · K780375

# PAVLIK HARNESS (K780375)

_Biomet, Inc. · IOZ · Mar 15, 1978 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOZ/K780375

## Device Facts

- **Applicant:** Biomet, Inc.
- **Product Code:** [IOZ](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOZ.md)
- **Decision Date:** Mar 15, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3665
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOZ/K780375](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOZ/K780375)

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