Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060) → PHQ — Anterior Staple As Supplemental Fixation For Fusion

# PHQ · Anterior Staple As Supplemental Fixation For Fusion

_Orthopedic · 21 CFR 888.3060 · Class 2_

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

## Overview

- **Product Code:** PHQ
- **Device Name:** Anterior Staple As Supplemental Fixation For Fusion
- **Regulation:** [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K200301](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PHQ/K200301.md) | UNiTi ACDF Implant System | Pressio, Inc. | Feb 3, 2021 | SESE |
| [K133906](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PHQ/K133906.md) | C-JAWS CERVICAL COMPRESSIVE STAPLE | Medicrea International | Jul 24, 2014 | SESE |

## Top Applicants

- Pressio, Inc. — 1 clearance
- Medicrea International — 1 clearance

---

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

**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