510(k) K103033

TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX by Zimmer Trabecular Metal Technology — Product Code ODP

K103033 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular Metal Technology for the device "TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX". The FDA issued a decision of Substantially Equivalent on January 10, 2011. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Zimmer Trabecular Metal Technology has at least 10 other 510(k) clearances on record.