5 spine, orthopedic products granted ‘breakthrough device’ designation in 2021

The FDA provides “breakthrough device” designation to products that are deemed effective to treat certain diseases and conditions. The designation speeds up the development, assessment and review for products.

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Five spine and orthopedic devices that earned the mark so far in 2021:

1. Premia Spine’s Tops facet arthroplasty system.

2. Cerapedics’ P-15L bone graft for the treatment of degenerative disc disease.

3. Spinal Stabilization Technologies’ PerQdisc.

4. Intelligent Implants’ remote orthopedics platform, SmartFuse

5. Hyalex Orthopaedics’ Hyalex Cartilage System.

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Register to Attend Webinar

Is ambulatory care healthcare’s big margin engine? 4 leaders weigh in

Wednesday, July 29
1:00 PM - 2:00 PM CDT

Presenters: Joe Ganley, athenahealthJeffrey Flynn, CASC, Gramercy Surgery CenterBryan Tsao, Access Center, Loma Linda University HealthJason Zepeda, Northridge Hospital Medical Center, CommonSpirit HealthGreg DeConciliis, PA-C, CASC, Boston Out­Patient Surgical Suites

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