Search Results
Found 1 results
510(k) Data Aggregation
K Number
K980457Device Name
ENDO ABSORBABLE INTERFERENCE SCREW
Manufacturer
Date Cleared
1998-09-08
(215 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ENDO SURGICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ENDO Absorbable Interference Screw is indicated for use in graft fixation in the repaid and reconstruction of the cruciate ligaments of the know, during open and arthroscoppic surgery.
Device Description
The ENDO Surgical Concepts, Inc. Absorbable Interference Screws have technological characteristics that are the same as absorbable bone and interference screws currently in interstate commerce that have been registered with the Food and Drug Administration under a 510(k). The subject screws are made of absorbable polymers such as polylactic acid, polyglycolic acid, or other, or copolymers. The competitive screws are comparable in the range of sizes, screw pitch, and hex sizes. The interference screws are also comparable in terms of clinical function to metallic interference screws and ligament buttons that have been registered under a 510(k) and used for fixation of grafts, as described in the attached articles.
Ask a Question
Ask a specific question about this device
Page 1 of 1