510(k) K241957

Talee, Talee PostOp by Invent Medical USA, LLC — Product Code MVA

K241957 is an FDA 510(k) premarket notification submitted by Invent Medical USA, LLC for the device "Talee, Talee PostOp". The FDA issued a decision of Substantially Equivalent on August 30, 2024. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970. Invent Medical USA, LLC has at least 2 other 510(k) clearances on record.