← Product Code [LGG](/submissions/OR/subpart-e%E2%80%94surgical-devices/LGG) · K851786

# 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF (K851786)

_Artiberia · LGG · Jul 9, 1985 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGG/K851786

## Device Facts

- **Applicant:** Artiberia
- **Product Code:** [LGG](/submissions/OR/subpart-e%E2%80%94surgical-devices/LGG.md)
- **Decision Date:** Jul 9, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.5980
- **Device Class:** Class 1
- **Review Panel:** Orthopedic

## Regulatory Identification

A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGG/K851786](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGG/K851786)

**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