Search Results
Found 1 results
510(k) Data Aggregation
K Number
K161446Device Name
Biopor Porous Polyethylene Implants
Manufacturer
Date Cleared
2016-09-27
(125 days)
Product Code
Regulation Number
882.5320Why did this record match?
Applicant Name (Manufacturer) :
Ceremed , Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Biopor® Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.
Device Description
Biopor® Porous Polyethylene Implants are manufactured of porous high-density polyethylene (PPE), a biomaterial that is contoured or carved to suit the anatomical and functional requirements of the patient. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend (AOC). Biopor® Porous Polyethylene Implants are provided STERILE and must not be resterilized.
Ask a Question
Ask a specific question about this device
Page 1 of 1