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Sign in to claim this brandACRA-CUT INC
US
Last updated May 24, 2026
What ACRA-CUT INC makes
ACRA-CUT Inc manufactures single-use and reusable neurosurgical instruments, including cranial trephines, automatic cranial perforators, and neurosurgical probes. Their portfolio also includes disposable orthopaedic bone pins/screws, scalp clip forceps and appliers, and non-medicated neurosurgical procedure kits designed for intraoperative use. Specific examples include distraction screws, cranial perforators, and low-speed cranial blades for cranial procedures.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. These instruments are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with US medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ACRA-CUT Inc manufacture?
ACRA-CUT Inc specializes in neurosurgical and orthopaedic instruments, including single-use and reusable devices. Their portfolio covers cranial trephines (both single-use and reusable), automatic cranial perforators, neurosurgical probes, scalp clip forceps and appliers, intraoperative orthopaedic bone pins/screws, and non-medicated neurosurgical procedure kits. These tools are designed for precision during cranial and orthopaedic surgeries, such as cranial perforations, bone pinning, and scalp clip applications.
Where is ACRA-CUT Inc based, and how does that affect its regulatory compliance?
ACRA-CUT Inc is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, ensuring they meet US compliance requirements. The UDI system helps track and identify devices throughout their lifecycle, while the 510(k) process demonstrates that new or modified devices are substantially equivalent to legally marketed predicates.
How are ACRA-CUT Inc’s devices classified under FDA regulations?
ACRA-CUT Inc’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body area involved—such as cranial or orthopaedic procedures—ensuring appropriate regulatory oversight.
Which regulatory registries list ACRA-CUT Inc’s devices?
ACRA-CUT Inc’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. The 510(k) registry tracks devices that have undergone a premarket submission to demonstrate equivalence to existing approved products, while the UDI system standardizes device identification for better tracking, traceability, and compliance monitoring in the US market.
Why do some of ACRA-CUT Inc’s devices have single-use designations while others are reusable?
ACRA-CUT Inc offers both single-use and reusable devices based on clinical needs, risk factors, and sterilization feasibility. Single-use instruments like cranial trephines, perforators, and orthopaedic pins/screws are designed for one-time use to reduce infection risks and ensure sterility. Reusable devices, such as scalp clip appliers or certain cranial trephines, are built to withstand repeated sterilization processes, balancing cost efficiency with safety for procedures where reuse is clinically justified.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- acracut.com
- —
- —
- [email protected]
- Phone
- 9782632210
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 612611459
Catalogue (80)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Distraction Screws Caspar type | 800-502 | FDA UDI | Class I | Active |
| Acra-Cut | 13/9mm DGR-II | FDA UDI | Class II | Active |
| Distraction Screws Caspar type | 800-502x | FDA UDI | Class I | Active |
| Cranial Blade Disposable low speed | 800-140 Single | FDA UDI | Class II | Active |
| Bone Pad Remover, Reusable | 800-020R | FDA UDI | Class I | Active |
| Acra-Cut Reusable Cranial Perforator | 200-141 DGR-I | FDA UDI | Class II | Active |
| Distraction Screws Caspar type | 800-501x | FDA UDI | Class I | Active |
| Acra-Cut | 14/11mm CDM | FDA UDI | Class II | Active |
| Dura Separator, Baker, Reusable | 800-715 | FDA UDI | Class I | Active |
| Dura Separator, Baker, Reusable | 800-719 | FDA UDI | Class I | Active |
| Cranial Blade Disposable low speed | 800-140 | FDA UDI | Class II | Active |
| Cranial Blade Disposable Low Speed | 800-130 Single | FDA UDI | Class II | Active |
| Distraction Screw Caspar type | 800-500 | FDA UDI | Class I | Active |
| Disposable Cranial Perforator | 200-241 14/11mm | FDA UDI | Class II | Active |
| Dura Separator, Baker, Reusable | 800-716 | FDA UDI | Class I | Active |
| Cranitomy Kit Disposable Low Speed | 400-101 | FDA UDI | N/A | Active |
| Wire Pass Drill | 800-330 Single | FDA UDI | Class II | Active |
| Acra Clip | 500-110 | FDA UDI | Class II | Active |
| Disposable Cranial Perforator | 200-243 11/7 mm | FDA UDI | Class II | Active |
| Acra Clip | 500-112 | FDA UDI | Class II | Active |
| Distraction Screws Caspar type | 800-501 | FDA UDI | Class I | Active |
| Dura Separator, Standard, Reusable | 800-711 | FDA UDI | Class I | Active |
| Dural Dissectors | K910226 | FDA 510(k) | Class I | Active |
| Acra-Cut Xpress 120 | K032970 | FDA 510(k) | Class II | Active |
| Acra-Cut | K833266 | FDA 510(k) | Class II | Active |
| Bone Pad Remover | K910225 | FDA 510(k) | Class I | Active |
| Acra-Cut Neurological Surgical Device-Powered | K911819 | FDA 510(k) | Class II | Active |
| Automatic Cranial Drill (perforator) | K892866 | FDA 510(k) | Class II | Active |
| Acra-Cut Wire Pass Drill | K911812 | FDA 510(k) | Class II | Active |
| Acra-Cut | K944311 | FDA 510(k) | Class II | Active |
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