Providence Medical Technology Receives 510(k) Clearance for PMT Bone Screws
SAN FRANCISCO--(BUSINESS WIRE)--Oct 24, 2012--Providence Medical Technology today announced that the company has received 510(k) clearance from the FDA to market PMT Bone Screws in the U.S.
“This clearance represents an important step in broadening our posterior cervical platform of single use disposable instruments and implants,” commented Jeff Smith, Chief Executive Officer of Providence Medical Technology. “Posterior indirect decompression and fusion provides a compelling minimally-invasive alternative for patients suffering from cervical radiculopathy.” The PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.
Providence’s posterior cervical platform now consists of DTRAX® Graft, DTRAX Cervical System, and PMT Bone Screws in the U.S., and the DTRAX Facet System outside of the U.S. Providence is finalizing manufacturing plans for the PMT Bone Screws and related delivery systems, and anticipates full market release during the first half of 2013.
“I am encouraged by our team’s ability to develop new products and gain necessary regulatory clearances to support our growing DTRAX platform,” continued Smith. “We have launched two new products in the U.S. in 2012, and anticipate two additional products in 2013.” Providence’s product portfolio and pipeline will be on display at the North American Spine Society (NASS) Annual Meeting, October 24-27, at the Dallas Convention Center, at Booth #2915.
About Providence Providence Medical Technology is a private corporation focused on developing novel minimally invasive technologies. We are commercializing the DTRAX platform of posterior cervical devices, which are used to provide indirect decompression and fusion in patients suffering from cervical degenerative disease.CONTACT: Providence Medical Technology David Schummers, 415-923-9376 firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA TEXAS INDUSTRY KEYWORD: SENIORS WOMEN HEALTH INFECTIOUS DISEASES MEDICAL DEVICES PHARMACEUTICAL BABY/MATERNITY CHILDREN PARENTING TEENS FDA CONSUMER FAMILY GAY & LESBIAN GENERAL HEALTH MEN SOURCE: Providence Medical Technology Copyright Business Wire 2012 PUB: 10/24/2012 01:39 PM/DISC: 10/24/2012 01:39 PM http://www.businesswire.com/news/home/20121024006409/