Intervertebral Disc Rongeur
FDA 510(k) K903151 · Von Zeppelin GmbH
510(k) numberK903151
Submission
- Device name
- Intervertebral Disc Rongeur
- Applicant
- Von Zeppelin GmbH
Pullach, DE - Received
- July 18, 1990
- Decision date
- December 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242759 | Geister K-Rex rongeursHAE · Traditional | Geister Medizin Technik GmbH | 06/06/2025SE |
| K223596 | SQ.line KERRISONHAE · Traditional | Aesculap, Inc. | 06/29/2023SE |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Special | Morpheus AG | 03/03/2023SE |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison RongeurHAE · Special | Morpheus AG | 10/07/2022SE |
| K210741 | KLS Martin Neuro RongeursHAE · Traditional | KLS-Martin L.P. | 06/03/2022SE |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Traditional | Morpheus AG | 05/04/2021SE |
| K200387 | Ace Medical Surgical InstrumentsHAE · Traditional | Ace Medical | 07/21/2020SE |
| K200383 | Wiggins Medical Surgical InstrumentsHAE · Traditional | Wiggins Medical | 07/21/2020SE |
| K180949 | SteribiteHAE · Traditional | Rjr Surgical, Inc. | 11/08/2018SE |
| K161744 | Symmetry Sharp Kerrison RongeurHAE · Special | Symmetry Surgical, Inc. | 09/07/2016SE |
More from Symmetry Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013091 | ZMM 2000 Zeppelin Millennium Motordrill SystemHBB · Traditional | 01/25/2002SE |
| K954658 | Perneczky Clip Applier/RemoverHCI · Traditional | 10/08/1996SE |
| K901312 | Perneczky Aneurysm ClipHCH · Traditional | 08/17/1990SE |
| K901313 | Instruments for Neurological SurgeryHAE · Traditional | 07/23/1990SE |
Questions and answers
When was Intervertebral Disc Rongeur cleared by the FDA?
Intervertebral Disc Rongeur (K903151) received a 510(k) decision of Substantially Equivalent on December 11, 1990, 146 days after the submission was received.
What is the product code of K903151?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.