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The Merete BLP™ Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

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This document is an FDA 510(k) clearance letter for the Merete BLP™ Small Fragment Locking Bone Plate System. It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, the letter does not describe any acceptance criteria or a study proving the device meets those criteria, as these are typically part of a device's submission which is not provided here. The 510(k) process for this type of device does not usually require clinical trials with human subjects or detailed performance studies against specific acceptance criteria in the same way a new, high-risk device might.

The letter focuses on regulatory clearance based on substantial equivalence to existing devices.

Based on the provided text, none of the requested information regarding acceptance criteria or a study that proves the device meets them can be extracted.

The document only serves as regulatory clearance and states the intended use and indications for the device.

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