Identity
- Trade Name
- ClearPoint FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- ClearPoint IMRIS T-Series Table Head Fixation Frame/Base FDA UDI
- Model / Reference
- CP-HFF-211-01 FDA UDI
- Description
- ClearPoint IMRIS T-Series Table Head Fixation Frame/Base FDA UDI
Identifiers
- Catalog Number
- CP-HFF-211-01 FDA UDI
- Primary DI / UDI-DI
- 00850376007048 FDA UDI
- 510(k) Number
- K091439 FDA UDI
- FDA Product Code
- HBL FDA UDI
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Skull clamp
ClearPoint by Clearpoint Neuro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skull clamp.
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- DORO® Base Unit — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- DORO® Skull Clamp System — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
Cleared under the same submission
K091439 also covers:
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
- ClearPoint — Clearpoint Neuro, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Clearpoint Neuro, Inc.
Sources (1)
- FDA UDI 2f91336d-3ecd-44e4-a7b5-63e37b172723 36 fields · synced May 30, 2026