Identity
- Trade Name
- SmartFrame FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- SMARTFrame Scalp Mount Rescue Screw - Long FDA UDI
- Model / Reference
- NGS-RS-02 FDA UDI
- Description
- SMARTFrame Scalp Mount Rescue Screw - Long FDA UDI
Identifiers
- Catalog Number
- NGS-RS-02 FDA UDI
- Primary DI / UDI-DI
- 00850359007409 FDA UDI
- 510(k) Number
- K200079 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Neurological stereotactic surgery system
SmartFrame by Clearpoint Neuro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200079 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 b4d1bf7a-b183-4a88-b6dd-f14efce9dc13 36 fields · synced May 30, 2026