Intervertebral Disc Rongeur
by Von Zeppelin GmbH 510(k)
Active
510(k) K903151
Overview
The Intervertebral Disc Rongeur is a manual surgical instrument classified as a Rongeur, Manual (FDA Class II, Product Code HAE). It features sharp, scoop-shaped jaws designed to excise or remove intervertebral disc material or bone fragments through a cutting or biting action during open surgical procedures. This device is specifically engineered for spinal applications, aiding in the removal of degenerative or herniated disc tissue to relieve neural compression or stabilize the spine.
Supplied as a reusable surgical tool, the Intervertebral Disc Rongeur is intended for use in sterile operating room environments by trained surgeons. It adheres to FDA regulatory standards under 21 CFR 882.4840 and holds a 510(k) clearance (K903151) with a Substantially Equivalent determination by the Neurology Advisory Committee. The device is not MRI-safe and requires proper sterilization and maintenance per manufacturer guidelines. No single-use or disposable variants are referenced in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903151 | Date11 Dec 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HAE
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4840
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Von Zeppelin GmbH
Questions
What is the Intervertebral Disc Rongeur used for?
The Intervertebral Disc Rongeur is designed specifically for spinal surgical procedures. Its sharp, scoop-shaped jaws allow surgeons to excise or remove intervertebral disc material or bone fragments, particularly in cases of degenerative or herniated discs. This helps relieve neural compression or stabilize the spine by clearing away problematic tissue during open surgical interventions.
Is the Intervertebral Disc Rongeur single-use or reusable?
The Intervertebral Disc Rongeur is supplied as a reusable surgical instrument. It is intended for use in sterile operating room environments and must be properly sterilized and maintained between procedures according to the manufacturer’s guidelines. There are no single-use or disposable variants referenced in the regulatory data.
How is the device sterilized and maintained?
Since the Intervertebral Disc Rongeur is reusable, it requires adherence to strict sterilization protocols to ensure patient safety. The manufacturer provides guidelines for proper sterilization and maintenance, which must be followed to prevent contamination or damage. These procedures are critical for preserving the instrument’s functionality and ensuring compliance with FDA regulatory standards.
Can this device be used in MRI environments?
No, the Intervertebral Disc Rongeur is not MRI-safe. This means it should never be used or stored in proximity to MRI machines, as the magnetic fields could cause damage to the device or pose risks to patients. Always verify the environment’s safety before use.
What regulatory approval does the Intervertebral Disc Rongeur hold?
The Intervertebral Disc Rongeur holds FDA 510(k) clearance (K903151) with a Substantially Equivalent determination by the Neurology Advisory Committee. It is classified under FDA Class II (Product Code HAE) and adheres to regulatory standards outlined in 21 CFR 882.4840. This clearance confirms its compliance with safety and effectiveness requirements for spinal surgical instruments.