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510(k) Data Aggregation
K Number
K973248Device Name
IMTEC BONE COLLECTOR SYSTEM
Manufacturer
Date Cleared
1997-11-19
(82 days)
Regulation Number
872.6640Why did this record match?
Product Code :
EHZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.
Device Description
The IMTEC Bone Collector System is designed to facilitate the collection of autogeneous bone for use in augmentation procedures. Adapted from an oral suction device it contains a filter cartridge which traps bone particles resulting from drilling into bone. The filter can be removed and the bone particles asceptically collected. The filters are available either sterile/single use or autoclavable. The autoclavable filter cartridge is not recommended for reuse in bone collection augmentation procedures.
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