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510(k) Data Aggregation
K Number
K093062Device Name
VERTOS MEDICAL MILD DEVICE KIT
Manufacturer
X-STEN CORP.
Date Cleared
2010-02-04
(127 days)
Product Code
HRX, HAE
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
X-STEN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vertos Medical mild® Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
Device Description
The Vertos Medical mild® Device Kit is a set of specialized arthroscopic surgical instruments. They are supplied sterile, for single use only.
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K Number
K062038Device Name
X-STEN MILD TOOL KIT, MODEL MTK-0001
Manufacturer
X-STEN CORP.
Date Cleared
2006-12-19
(153 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
X-STEN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Device Description
The X-Sten MILD Tool Kit is a set of specialized surgical tools for retracting, grasping and excising tissue in the lumbar spine. The kit consists of the following components:
- MILD Tissue Retractor Cobra Device 8.5 Gauge, 8.5" working length .
- MILD Trocars and Handles- 7 Gauge, 6.5" working length ●
- MILD Portals 6 Gauge, 6.5" working length ●
- Surgical Clamp 14" length .
The Trocars, Portals (cannula) and Retractor devices contain stainless steel shafts and plastic handle components. The radiopaque tip and pistol-grip handle aid the user in the Minimally Invasive Lumbar Decompression (MILD) Retractor device positioning and Under fluoroscopic imaging guidance, the MILD Retractor device is advancement. inserted through the Portal into the posterior lumbar spine to retract and grasp tissue. An accessory Clamp can be used to position the Portal and allow handling outside of the fluoroscopic imaging field. A cutting mechanism on the MILD Retractor is advanced by depressing a handle trigger. Excised tissue is removed using an integrated member.
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