Search Results

Miltex® Membrane Tack Kit is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site.

The Miltex® Membrane Tack Kit consists of non-sterile, single use titanium alloy tacks available in 3 mm or 5 mm lengths. Membrane Tacks are used in conjunction with the following accessories and reusable stainless steel instruments for implantation: Tack Membrane Probe, Tack Applicator, Perforation Raspatory, Kirsch Sinus 7 Double-ended Spoon and Plugger, Sinus Elevator, Mixing Cup with Plastic Lid, Tack Storage Box for 15 Tacks and Tack Wash Tray with Lid.

The provided text is a 510(k) Summary for the Miltex® Membrane Tack Kit. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is the basis for 510(k) clearance. This process relies on demonstrating that the new device has the same intended use, fundamental technology, design, and material as legally marketed predicate devices, rather than on specific performance metrics or clinical studies with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text only establishes the device's identity, intended use, and substantial equivalence to existing devices.

Ask a specific question about this device