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510(k) Data Aggregation
K Number
K010542Device Name
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
Manufacturer
Date Cleared
2001-05-08
(74 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL NAVIGATION SPECIALISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K994421Device Name
SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
Manufacturer
Date Cleared
2000-02-23
(56 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL NAVIGATION SPECIALISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SNN Stereotactic Planning Application module is intended to be used as an accessory for planning stereotactic frame-based procedures such as biopsies, functional stereotaxy, turnor resections, vascular malformation surgeries, thalamotomies and pallidotomies.
Device Description
The SNN Stereotactic Planning Application software is an optional module of the SNN System software. The SNN Stereotactic Planning Application module registers medical scan images with stereotactic frame space and calculates frame and arc system coordinates.
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K Number
K992457Device Name
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
Manufacturer
Date Cleared
1999-08-27
(35 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL NAVIGATION SPECIALISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SNN system with the Olivier Double-Chuck Support Arm Option is indicated for patients who have space occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine.
The Olivier Double-Chuck Support Arm Option can provide mechanical support and guidance for vanous frameless stereotaxic procedures, turnor resections, biopsies, and endoscopies.
The SNN system is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
Device Description
The Olivier Double-Chuck Support Arm is an optional component of the SNN image-guided surgical system. The arm itself can be positioned and locked into place. The double-chuck head has one chuck to firmly hold a surgical instrument in the desired location. The instrument can also be moved up or down by sliding it through the chuck. The second chuck is used to prevent excessive vertical movement, by stabilizing the arm against the skull.
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