510(k) K190563

4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage by Solco Biomedical Co., Ltd. — Product Code MAX

K190563 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage". The FDA issued a decision of Substantially Equivalent on September 18, 2019. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Solco Biomedical Co., Ltd. has at least 10 other 510(k) clearances on record.