7 spine devices earning FDA approval in 45 days

Here are seven spine devices that have received FDA clearance that Becker’s has reported on since April 16:

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1. Spineart received FDA 510(k) clearance for its SCARLET AC-Ti secured anterior cervical cage.

2. Orthopedic technology company Implanet earned FDA clearance for its hybrid fixation system, the Jazz Spinal System. 

3. ZygoFix earned FDA clearance for its zLock device.

4. Spinal Simpicity’s Patriot-SI posterior implant system for sacroiliac joint fusion earned FDA 510(k) clearance.

5. Medtronic earned FDA approval for its Inceptiv closed-loop spinal cord stimulator.

6. SAIL Fusion earned FDA clearance for its BowTie sacroiliac joint fusion system.

7. Xstim earned FDA premarket application approval for its spine fusion stimulator.

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.

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