510(k) K982354

SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M by Special Devices, Inc. — Product Code HTN

K982354 is an FDA 510(k) premarket notification submitted by Special Devices, Inc. for the device "SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M". The FDA issued a decision of Substantially Equivalent on November 23, 1998. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Special Devices, Inc. has at least 1 other 510(k) clearance on record.