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510(k) Data Aggregation
K Number
K090695Device Name
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
Manufacturer
DINKLER SURGICAL DEVICES, INC.
Date Cleared
2009-04-23
(38 days)
Product Code
HBL
Regulation Number
882.4460Why did this record match?
Applicant Name (Manufacturer) :
DINKLER SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dinkler Surgical Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
Device Description
The Dinkler Surgical Skull Clamp is a device used for rigid fixation of the skull. The design of the Skull Clamp allows the surgeon more freedom in positioning the skull pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arc which rotates 360°. The main body of the clamp is made from aluminum. The rocker arc assembly, which houses an additional skull pin, is made from stainless steel. A torque screw device on the main body of the clamp is used to apply load to the skull mainly for support and an additional torque screw, on the arc, provides load to resist head rotation. To accommodate the different sizes of patient heads, the skull clamp can be slid opened or closed and then locked.
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K Number
K073163Device Name
LIMITED ARTIFACT SKULL PIN, MODEL 0107
Manufacturer
DINKLER SURGICAL DEVICES, INC.
Date Cleared
2008-02-28
(111 days)
Product Code
HBL
Regulation Number
882.4460Why did this record match?
Applicant Name (Manufacturer) :
DINKLER SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Limited Artifact Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is required and during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.
The Limited Artifact Skull Pins are used in open and percutaneous craniotomies such as biopsies, thalamotomies and electrode implants; and in spinal surgeries when rigid skeletal fixation is necessary. The pins are also indicated for use during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.
Device Description
The Limited Artifact Skull Pins consists of an injection molded PEEK polymer base, a machined titanium pin tip, and an O-ring. These components are assembled to each other to represent the finished skull pin. The pins are packaged three (3) pins per pouch, twelve (12) pouches per carton and radiation sterilized.
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