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510(k) Data Aggregation
K Number
K220966Device Name
SINEFIX
Manufacturer
Date Cleared
2023-03-08
(341 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BAAT Medical Products B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.
Device Description
The SINEFIX is a PEEK implant which can be used to re-attach a ruptured rotator cuff tendon to the humerus of the shoulder. The implant can be used to re-attach complete or partially ruptured tendons up to 2 cm to facilitate the healing of the natural bone-tendon interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the tendon and attached to the humerus with the anchors. The medial anchor goes through the tendon, while the lateral anchor goes directly into the bone, lateral of the tendon.
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