In Brief: American Medical Electronics
This article was originally published in The Gray Sheet
Executive Summary
American Medical Electronics: Richardson, Texas-based bone healing products manufacturer receives additional 510(k) clearances from FDA for its Ogden anchor soft tissue reattachment devices. The company says its 7.4 mm anchor, cleared in 1993 for soft tissue reattachment in torn rotator cuffs, has been cleared for "expanded shoulder applications and multiple soft tissue, orthopedic attachment applications in the knee." In addition, AME's 5.5 mm anchor received FDA clearance for use in the shoulder, elbow, wrist, knee, ankle, and foot...