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510(k) Data Aggregation
K Number
K993501Device Name
3D1 MICROPOSITIONING HEADSTAGE
Manufacturer
Date Cleared
1999-11-22
(38 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
SCIENTIFIC TOOLS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 3D1 Micropositioning Headstage is indicated for use by a qualified neurosurgeon when precise movement of a surgical instrument is needed along any of three axes. The 3D1 Micropositioning Headstage is intended to be used with a standard stereotactic headframe system.
Device Description
The 3D1 Micropositioning Headstage is a device that allows for precise positioning of a neurosurgical instrument along three axes. The device is used in neurosurgical procedures in conjunction with a conventional stereotactic head frame and serves as an accessory to those devices. The 3D1 device comes with a mounting adaptor that is specific for the particular stereotactic head frame being used.
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