(86 days)
This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation.
Not Found
The provided document is an FDA 510(k) clearance letter for the Bone-Lok™ Bioabsorbable Compression Anchor. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a notification of the FDA's determination that the device is substantially equivalent to legally marketed predicate devices, allowing Triage Medical, Inc. to market the device. It focuses on regulatory compliance, general controls, and classification.
Therefore, I cannot provide the requested information based on the input document. The document primarily addresses regulatory clearance rather than detailed performance study results.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.