Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3910](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3910) → NOC — Splint, Extremity, Non-Inflatable, External, Non-Sterile

# NOC · Splint, Extremity, Non-Inflatable, External, Non-Sterile

_General, Plastic Surgery · 21 CFR 878.3910 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NOC

## Overview

- **Product Code:** NOC
- **Device Name:** Splint, Extremity, Non-Inflatable, External, Non-Sterile
- **Regulation:** [21 CFR 878.3910](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3910)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **GMP exempt:** yes

## Identification

A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NOC](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NOC)

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