510(k) K024199

IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP by Osteobiologics, Inc. — Product Code FTL

K024199 is an FDA 510(k) premarket notification submitted by Osteobiologics, Inc. for the device "IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP". The FDA issued a decision of Substantially Equivalent on March 14, 2003. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Osteobiologics, Inc. has at least 8 other 510(k) clearances on record.