← Back to catalogue
ClearPoint Multi-Positional Upper Fixation Frame Screws
EUDAMEDFDA UDIClass I (EU MDR)
Ref CP-FFSMPU-01
Identity
- Trade Name
- ClearPoint Multi-Positional Upper Fixation Frame Screws EUDAMEDClearPoint FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- ClearPoint Multi-Positional HFF Screws EUDAMEDClearPoint Multi-Positional Upper Fixation Frame Screws FDA UDI
- Model / Reference
- CP-FFSMPU-01 EUDAMEDFDA UDI
- Description
- ClearPoint Multi-Positional Upper Fixation Frame Screws FDA UDI
Identifiers
- Catalog Number
- CP-FFSMPU-01 FDA UDI
- Primary DI / UDI-DI
- 00850376007376 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850376007378D EUDAMED
- 510(k) Number
- K091439 FDA UDI
- FDA Product Code
- HBL FDA UDI
- EMDN Code
- Z12100680 STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4460 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
MR Safe FDA UDI
ClearPoint Multi-Positional Upper Fixation Frame Screws by Clearpoint Neuro, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850376007378D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ClearPoint Neuro, Inc.
- EUDAMED SRN
- US-MF-000010239
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 89e07a41-db37-4914-a5c0-28d1606f9e43 61 fields · synced Jul 14, 2026
- FDA UDI 5fd07d38-75b1-4db9-a8d8-38b8e2b41386 36 fields · synced May 30, 2026