FDA 510(k) Applications for Medical Device Product Code "HAE"
(Rongeur, Manual)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200387 | Ace Medical | Ace Medical Surgical Instruments | 07/21/2020 |
| K223596 | Aesculap Inc. | SQ.line KERRISON | 06/29/2023 |
| K080494 | BAXANO, INC. | BAXANO ULTRA LOW PROFILE RONGEUR | 03/04/2008 |
| K113073 | BAXANO, INC. | IO-TOME DEVICE | 07/27/2012 |
| K063231 | BAXANO, INC. | MICROBLADE SHAVER AND ACCESSORIES | 04/16/2007 |
| K100958 | BAXANO, INC. | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | 07/23/2010 |
| K113533 | BAXANO, INC. | NEURO CHECK DEVICE WITH IO-FLEX WIRE | 04/11/2012 |
| K062711 | BAXANO, INC. | ULTRA LOW PROFILE RONGEUR | 03/07/2007 |
| K023868 | DANNORITZER MEDICAL INSTRUMENTS | DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 | 02/07/2003 |
| K153243 | Fehling Instruments GmbH & Co. KG | Fehling-Punches | 08/04/2016 |
| K081651 | INSTRUMED INTERNATIONAL, INC. | INSTRUMED RONGEUR | 08/08/2008 |
| K150428 | INTEGRA LIFESCIENCES CORP. | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs | 04/16/2015 |
| K092227 | INTEGRA LIFESCIENCES CORP. | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | 02/17/2010 |
| K150468 | K2 Medical GmbH & Co. KG | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | 02/29/2016 |
| K210741 | KLS-MARTIN L.P. | KLS Martin Neuro Rongeurs | 06/03/2022 |
| K230256 | Morpheus AG | Rebellion, Phantom Multi-Bite Kerrison Rongeur | 03/03/2023 |
| K200768 | Morpheus AG | Rebellion, Phantom Multi-Bite Kerrison Rongeurá | 05/04/2021 |
| K221818 | Morpheus AG | Rebellion; Phantom Multi-Bite Kerrison Rongeur | 10/07/2022 |
| K131851 | OSTEOMED | OSTEOMED NEURO RONGEUR | 12/06/2013 |
| K180949 | RJR Surgical, Inc. | Steribite | 11/08/2018 |
| K130541 | SYMMETRY SURGICAL | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | 08/05/2013 |
| K161744 | Symmetry Surgical Inc. | Symmetry Sharp Kerrison Rongeur | 09/07/2016 |
| K152734 | VITALITEC MEDIZINTECHNIK GMBH | Kerrison Rongeurs | 06/18/2016 |
| K200383 | Wiggins Medical | Wiggins Medical Surgical Instruments | 07/21/2020 |
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