FDA Registration
Active
🇺🇸 United States
ACRA CUT, INC.
Reg #: 1220724
·
FEI: 1220724
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ACRA CUT, INC.
- Registration Number
- 1220724
- FEI Number
- 1220724
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 989 MAIN ST.
- City
- ACTON
- State
- MA
- ZIP
- 01720
- Country
- US
Regulatory Submissions
- 510(k) Number
- K911812
Owner / Operator
- Firm Name
- ACRA CUT, INC.
- Operator Number
- 1220724
- Address
- 989 MAIN ST., --
- City
- Acton
- State
- MA
- Postal Code
- 01720
- Country
- US
- Correspondent
- JOHN W BAKER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2007-11-19 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2007-11-19 |
| Instrument, Clip Removal | HBQ | Class 1 | Neurology | No | 2000-06-05 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2000-06-05 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2000-06-05 |
| Clip, Scalp | HBO | Class 2 | Neurology | No | 2007-11-19 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2000-06-05 |
Proprietary Names
Acra Cut Wire Pass Drill
Acra Cut Xpress Drills
Acra Cut Cranial Perforators
ACRA-CUT CLIP APPLIER
ACRA GUN
Acra Cut Distraction Screw
Acra Cut Cranial Blades
Acra Cut Scalp Clips
Acra Cut Dura Separators
Establishment Types
Manufacture Medical Device