Identity
- Trade Name
- MAYFIELD® FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- KNOB/INSERT ASSEMBLY FDA UDI
- Model / Reference
- 437A1105 FDA UDI
- Description
- KNOB/INSERT ASSEMBLY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780255086 FDA UDI
- 510(k) Number
- K953124 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
No
FDA UDI
Category: Skull clamp
Mayfield® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skull clamp.
- 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
- ClearPoint — Clearpoint Neuro, Inc. · Class II
- DORO® pin holder — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- DORO® Quick-Clamp — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- V. Mueller — STERIS CORPORATION · Class II
- ClearPoint — Clearpoint Neuro, Inc. · Class II
- DORO® Base Unit Radiolucent — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
Cleared under the same submission
K953124 also covers:
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
- MAYFIELD® — Integra Lifesciences Corp.
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
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI d3043f1c-e4ae-4598-a7fb-3a33bc5f7f88 35 fields · synced May 30, 2026