08.07.13
San Clemente, Calif.-based Dallen Medical Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a polymer coated Compressyn band for sternal closure. In the past 18 months, the FDA has also cleared Dallen’s non-coated Compressyn band and the Compressyn staple for foot, ankle and hand fixation and repair.
“This clearance reflects Dallen’s response from physicians and marks the expansion of the Compressyn product line,” said David Mills, president and CEO of Dallen. “Our coated version provides the company with future opportunities to penetrate the sternal closure market which, in the United States alone, represents over 445,000 procedures annually.”
“As a permanent implant, the coated Compressyn band opens the door to offering this polymer coating to future banding technologies,” added Chief Operating Officer Al Memmolo.
The company is currently waiting on clearance for its proprietary Tensyn band for syndesmosis (a slightly moveable joint where bones are connected by an interosseous ligament) repair. Dallen submitted the 510(k) application in July.
Dallen Medical develops bone fixation and repair technologies and devices.
“This clearance reflects Dallen’s response from physicians and marks the expansion of the Compressyn product line,” said David Mills, president and CEO of Dallen. “Our coated version provides the company with future opportunities to penetrate the sternal closure market which, in the United States alone, represents over 445,000 procedures annually.”
“As a permanent implant, the coated Compressyn band opens the door to offering this polymer coating to future banding technologies,” added Chief Operating Officer Al Memmolo.
The company is currently waiting on clearance for its proprietary Tensyn band for syndesmosis (a slightly moveable joint where bones are connected by an interosseous ligament) repair. Dallen submitted the 510(k) application in July.
Dallen Medical develops bone fixation and repair technologies and devices.