← Product Code [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX) · K010246

# KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A (K010246)

_Kyphon, Inc. · HRX · Feb 14, 2001 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K010246

## Device Facts

- **Applicant:** Kyphon, Inc.
- **Product Code:** [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX.md)
- **Decision Date:** Feb 14, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.1100
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K010246](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K010246)

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