510(k) Report

Devices descending from K020663

110 later devices reach Modification to Sparc Sling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K242187BioBrace®Conmed Corporation20241—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K173527Digitex Delivery DeviceColoplast A/S20180—
+7K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+7K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+7K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—