VIRGINIA BEACH, Va., Dec. 1 /PRNewswire/ -- LifeNet announced today that the Food and Drug Administration (FDA) has cleared the company’s 510(k) PreMarket Notification for their OPTIUM DBM(TM) family of products.
OPTIUM DBM(TM) Gel and OPTIUM DBM(TM) Putty are bone void fillers comprised of LifeNet’s proprietary demineralized bone matrix that have been used in orthopedics and neurosurgery for more than three years.
OPTIUM DBM(TM) Gel and OPTIUM DBM(TM) Putty are indicated for bony voids or gaps in the musculoskeletal system due to trauma, injury, or surgical necessity. The OPTIUM DBM(TM) family of products provide a bone void filler that remodels into the recipient’s musculoskeletal system and promotes bone growth.
Richard L. Hurwitz, MD, President and CEO of LifeNet stated, “We are pleased to have our 510(k) for our OPTIUM DBM(TM) family of products cleared by the FDA. We have worked diligently with the agency to bring this process to conclusion for our products.”
For more information on LifeNet, visit http://www.accesslifenet.org.
LifeNet
CONTACT: Douglas B. Wilson of LifeNet, +1-800-847-7831