(87 days)
The DRG Sherlock™ Threaded Anchor is for the fixation of nonabsorbable braided polyester surgical suture to bone for the indications listed below. WRIST/HAND Scapholunate ligament reconstruction Thumb ulnar collateral ligament reconstruction SKULL Endoscopic Brow lifts
Sherlock™ TiN Coated Threaded Suture Anchors
The provided text is a 510(k) premarket notification approval letter for the "Sherlock™ Threaded Suture Anchor (TiN Coated)" and its associated indications for use. This document confirms the device's substantial equivalence to a predicate device but does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot extract the requested information from this document. The document is a regulatory approval, not a performance study report.
§ 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.