Identity
- Trade Name
- neuro|mate® frameless Gen II stereotactic system FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- neuro|mate® is an image-guided, computer-controlled, 5-axis articulated arm. It is intended for use in an operating room to position and orientate as prescribed by the surgeon a guide into which the surgeon can manually insert standard stereotactic instruments. neuro|mate® provides the surgeon with precise, reliable, and reproducible mechanical assistance in order to guide instruments during surgical interventions. neuro|mate® could be considered as a motorised stereotactic frame controlled by interactive PC-based imaging software which provides three-dimensional images of the anatomical structures of the brain as well as the target points. The neuro|mate® is a configurable medical device that is composed of a mobile support with or without a spacer, an arm, a planning trolley (with a planning station and a planning software), a remote control and cables. FDA UDI
- Model / Reference
- neuro|mate v1.5 FDA UDI
- Description
- neuro|mate® is an image-guided, computer-controlled, 5-axis articulated arm. It is intended for use in an operating room to position and orientate as prescribed by the surgeon a guide into which the surgeon can manually insert standard stereotactic instruments. neuro|mate® provides the surgeon with precise, reliable, and reproducible mechanical assistance in order to guide instruments during surgical interventions. neuro|mate® could be considered as a motorised stereotactic frame controlled by interactive PC-based imaging software which provides three-dimensional images of the anatomical structures of the brain as well as the target points. The neuro|mate® is a configurable medical device that is composed of a mobile support with or without a spacer, an arm, a planning trolley (with a planning station and a planning software), a remote control and cables. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662724000024 FDA UDI
- 510(k) Number
- K132755 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurological stereotactic surgery system
neuro|mate® frameless Gen II stereotactic system by Renishaw Mayfield — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurological stereotactic surgery system.
- Gauge for Softouch Registration Pointer — Brainlab SE · Class I
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- Mini-Bolt VUE Accessory Kit — MONTERIS MEDICAL CORP · Class I
- StealthAiR™ Spine — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
- PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
Cleared under the same submission
K132755 also covers:
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool-holder — RENISHAW MAYFIELD
- neuro|mate® - Adaptation for CRW Integra frame — RENISHAW MAYFIELD
- neuro|mate® - Adaptation for Leksell Model G Elekta frame — RENISHAW MAYFIELD
- neuro|mate® - Laser tool-holder — RENISHAW MAYFIELD
- neuro|mate® - Registration frame — RENISHAW MAYFIELD
- neuro|mate® - Tool-holder fixation screw — RENISHAW MAYFIELD
- neuro|mate® - Tool-holder locking screw — RENISHAW MAYFIELD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Renishaw Mayfield
Sources (1)
- FDA UDI 94195827-c2b0-4f6a-86e9-327a5f8b391c 35 fields · synced May 30, 2026