← Product Code LWE · K913306

# BONE-TEMNO/STERNUM-TEMNO (K913306)

_Proact, Ltd. · LWE · Nov 1, 1991 · HO · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K913306

## Device Facts

- **Applicant:** Proact, Ltd.
- **Product Code:** LWE
- **Decision Date:** Nov 1, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class 2
- **Review Panel:** HO

## Regulatory Identification

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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**Source:** [https://fda.innolitics.com/device/K913306](https://fda.innolitics.com/device/K913306)

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