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510(k) Data Aggregation
K Number
K213777Device Name
Stryker Resorbable Fixation System
Manufacturer
Stryker Leibinger Micro Implants
Date Cleared
2022-02-04
(63 days)
Product Code
JEY, GXR, HBW
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
Stryker Leibinger Micro Implants
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental: The Delta Resorbable Fixation System is intended for use in the fixation of bones of the maxillofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.
Neuro: The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.
Device Description
The Stryker Resorbable Fixation System is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide.
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K Number
K051603Device Name
STRYKER INJECTABLE CEMENT
Manufacturer
STRYKER LEIBINGER MICRO IMPLANTS
Date Cleared
2005-12-30
(198 days)
Product Code
MQV, FMF
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
STRYKER LEIBINGER MICRO IMPLANTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Device Description
Stryker® Injectable Cement is a self-setting calcium phosphate cement.
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