510(k) K220681

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

K220681 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 September 22, 2022. 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.