Kent Medical Device's long-term implantable device for radiographically marking soft tissue sites during and after surgical procedures has been approved in the US.
The KMD-Mark1, manufactured with Oxford Performance Materials (OPM) radio-opaque OXPEKK-IG polymer containing barium sulfate, received 510(k) Clearance from the US Food and Drug Administration (FDA).
OPM's OXPEKK-IG polymer is a high-performance, ultra-pure thermoplastic with properties very similar to bone, supported by comprehensive ISO 10993 biocompatibility and purity data.
The OXPEKK-IG polymer has also been given the CE Mark and has received market clearance from the Korean Food and Drug Administration.
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