Drills, Burrs, Trephines & Accessories (Compound, Powered)
FDA product code HBF · Class II (moderate risk) · 21 CFR 882.4305 · Neurology
19510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Codman & Shurtleff, Inc. 6
- Acra Cut, Inc. 3
- The Anspach Effort, Inc. 2
- Neurodynamics, Inc. 1
- Stryker Ireland Ltd., Instruments Division 1
- Adeor Medical Technologies GmbH 1
- Micromar Ind. Com. , Ltd. 1
- Integra LifeSciences Corp. 1
- Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. 1
- Evonos GmbH & Co. KG 1
- Guizhou Zirui Technology Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254177 | Disposable Sterile Skull Drill (LZ)HBF · Traditional | Guizhou Zirui Technology Co., Ltd. | 09/11/2026SE |
| K231403 | evoDrill Cranial PerforatorHBF · Traditional | Evonos GmbH & Co. KG | 03/06/2024SE |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson endHBF · Traditional | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 06/20/2022SE |
| K183581 | Codman Disposable PerforatorsHBF · Special | Integra Lifesciences Corp. | 01/20/2019SE |
| K141455 | Easydrill Autostop Cranial PerforatorHBF · Traditional | Micromar Ind. Com. , Ltd. | 03/16/2015SE |
| K121253 | Meridian Cranial PerforatorHBF · Traditional | Adeor Medical Technologies GmbH | 07/17/2012SE |
| K082010 | Stryker Disposable Cranial Perforator BitHBF · Traditional | Stryker Ireland Ltd., Instruments Division | 12/29/2008SE |
| K082637 | Cranial PerforatorHBF · Traditional | The Anspach Effort, Inc. | 12/22/2008SE |
| K073336 | Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231HBF · Special | Codman & Shurtleff, Inc. | 01/04/2008SE |
| K071931 | Codman Disposable Perforator, Model(S) 26-1222, 26-1223HBF · Traditional | Codman & Shurtleff, Inc. | 10/22/2007SE |
| K032970 | Acra-Cut Xpress 120HBF · Traditional | Acra Cut, Inc. | 12/08/2003SE |
| K982991 | Anspach Access Cranial PerforatorHBF · Traditional | The Anspach Effort, Inc. | 10/21/1998SE |
| K933894 | Disposable PerforatorHBF · Traditional | Codman & Shurtleff, Inc. | 12/10/1993SE |
| K924242 | Disposable PerforatorHBF · Traditional | Codman & Shurtleff, Inc. | 07/08/1993SE |
| K892866 | Automatic Cranial Drill (Perforator)HBF · Traditional | Acra Cut, Inc. | 06/15/1989SE |
| K875019 | Ghajar Guide System for the PerforatorHBF · Traditional | Neurodynamics, Inc. | 01/22/1988SE |
| K833266 | Acra-CutHBF · Traditional | Acra Cut, Inc. | 12/29/1983SE |
| K820087 | Codman * Reusable PerforatorHBF · Traditional | Codman & Shurtleff, Inc. | 02/04/1982SE |
| K791101 | Disposable Perforators, Jacobs, HudsonHBF · Traditional | Codman & Shurtleff, Inc. | 08/28/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0374-2026 Class I | CODMAN Disposable Perforator 9mm. Cranial Perforator.Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm… | Integra LifeSciences Corp. (NeuroSciences) | 09/26/2025Open, Classified |
| Z-0373-2026 Class I | CODMAN Disposable Perforator 11mm. Cranial Perforator.Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm… | Integra LifeSciences Corp. (NeuroSciences) | 09/26/2025Open, Classified |
| Z-1717-2025 Class I | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial…Inadequate weld that can potentially cause the product to disassemble. | Integra LifeSciences Corp. (NeuroSciences) | 04/11/2025Open, Classified |
| Z-1716-2025 Class I | CODMAN Disposable Perforator, 14mm. Cranial perforator.Inadequate weld that can potentially cause the product to disassemble. | Integra LifeSciences Corp. (NeuroSciences) | 04/11/2025Open, Classified |
| Z-0431-2021 Class II | Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use…Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal… | Stryker Instruments Div. of Stryker… | 10/16/2020Terminated |
| Z-0447-2012 | Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L)…Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure… | Biomet Microfixation, Inc. | 07/08/2011Terminated |