Life Spine announced that it won FDA 510(k) clearance for its Longbow titanium lateral expendable spacer system. The Longbow system is the first interbody on the market that expands laterally in-situ, specifically for a direct lateral approach, according to Life Spine’s website. Longbow is designed to minimize tissue retraction and potential nerve damage associated with […]
Life Spine
Life Spine, execs agree to $6m settlement in kickbacks case
Life Spine and its two top executives agreed to collectively pay nearly $6 million to settle charges that they ran an illegal kickbacks scheme to promote the use of its orthopedic implants. The case dates back to February 2018, when a quartet of anonymous whistleblowers filed a False Claims Act suit alleging that the Huntley, […]
Life Spine targeted in alleged kickback scheme
The federal government has accused Life Spine of paying millions of dollars in kickbacks to surgeons — enough to account for half of the company’s total domestic sales from 2012 through 2018. The civil suit against the Huntley, Ill.-based company claims that Life Spine violated the False Claims Act by allegedly paying surgeons consulting fees, […]
FDA clears Life Spine’s surgical spacer system
Life Spine said that the FDA has granted 510(k) market clearance for the company’s Prolift lateral expandable spacer system. The system features minimal insertion height and controlled, in situ expansion, which are critical components in a minimally invasive expandable lateral interbody fusion procedure, according to the Huntley, Ill.-based company. “The Prolift lateral expandable spacer system […]
7 medtech stories we missed this week: April 21, 2017
From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer […]
NASS 2016: Interest grows in surgical robotics for spinal procedures
Mazor Robotics (NSDQ:MZOR) unveiled its next-generation robot-assisted surgery system and Globus Medical (NYSE:GMED) for the 1st time showcased the functional prototype of its Excelsius platform at the NASS 2016 meeting in Boston last week, signifying an increased interest in robotic surgeons among major players. Mazor developed 3 generations of products over 15 years and does 95% of its business in […]
FDA clears Life Spine’s Pro-Link Ti cervical spacer
Life Spine said today that it won 510(k) clearance from the FDA for its Pro-Link Ti cervical spacer. The Huntley, Ill.-based company said the product is slated for full release by the end of 2016, joining a portfolio of devices that Life Spine launched this year. The spacers allow for the fusion of adjacent segments […]
Life Spine’s foot & ankle division, Centric Medical, wins FDA nod for flatfoot implant
Centric Medical, the foot & ankle division of Life Spine, said yesterday that it won 510(k) clearance from the FDA for its subtalar arthroereisis implant for treating flatfoot deformities. The device is a 1-piece titanium implant designed to block forward, downward and medial displacement of the talus to allow normal articulation of the subtalar joint. The device is slated for limited release at […]
FDA clears Life Spine’s Gruve cervical plate implant
Life Spine said yesterday it won FDA 510(k) clearance for its Gruve anterior cervical plate system. The Gruve plate allows for extreme bone screw angulation, large graft windows and a locking mechanism that provides tactile and visual confirmation of locking upon installation, Huntley, Ill.-based Life Spine said. “Our comprehensive cervical portfolio reinforces Life Spine’s commitment to […]
BSX wins CE Mark, FDA approval for spinal cord stims | Regulatory news for the week of October 27, 2014
Boston Scientific wins CE Mark, FDA nod for spinal surgical leads
October 21, 2014 by Brad Perriello
Life Spine creates Centric Medical ankle & foot unit
Life Spine launched a new division called Centric Medical, after receiving FDA marketing clearance for its Tarsa-Link system for internal bone fixation of fractures, fusions, and osteotomies in the foot and ankle.