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510(k) Data Aggregation
K Number
K080430Device Name
STOMA BONE BLOCK SCREW
Manufacturer
STORZ AM MARK GMBH
Date Cleared
2008-11-21
(276 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
STORZ AM MARK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STOMA bone block screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field.
STOMA bone block screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.
Device Description
The screw head has either an inner square, or a cross slot. The screw thread is self-tapping and has two different thread leads. Dimensions: Length: 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm; Diameter: ø1.0 mm, ø1.2 mm, ø1.6 mm. The screws can be delivered in a cassette along with suitable accessories such as a screwdriver and pilot drill as basic equipment or re-ordered separately in different packaging units.
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K Number
K051871Device Name
STOMA BONE SCREW
Manufacturer
STORZ AM MARK GMBH
Date Cleared
2005-10-27
(108 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
STORZ AM MARK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.
Device Description
STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants. The bolt head of the STOMA Bone Screw is either self tapped by a square, hexagon or cross slot. The screws will be delivered in a cassette / container including accordingly screw driver and pilot drill. The bone screws are available in 1.3mm in length 4 mm to 1.6mm and 2.0mm diameter and lengths ranging from 4mm to 16mm.
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