16 Spine Devices Receive FDA 510(k) Clearance in November FeaturedWritten by Laura Dyrda | Monday, 17 December 2012 16:45
The Food and Drug Administration granted 16 spine-related clearances in November.
1. Frontier Sadl Interbody Fusion Device from Frontier Medical Devices.
2. Lite Decompression System from Stryker Spine.
3. Dymaxeon Spine System from B2B Spine.
4. Pioneer Posterior Occipito-Cervico-Thoracitc System from Pioneer Surgical Technology.
5. Vertiflex Direct Compression System from Vertiflex.
6. Pro-Link Cervical Spacer System from Life Spine.
7. CD Horizon Spire Z Spinal System from Medtronic Sofamor Danek.
8. Incite Anchored Cervical Interbody Fusion Device from Incite Innovation.
9. Synthes Matrixmadible Plate and Screw System from Synthes.
10. Zou Anterior Lumbar Plate System from Corelink.
11. Loqteq Distal Lateral Femur Plate, Cortical Screw from Aap Implantante.
12. S-Lok PSS System from Spinal USA.
13. Viceroy Spinal System from Torrey Spine.
14. Illico FS Facet Fixation System from Alphatec Spine.
15. Construx Mini PEEK TI Spacer System from Orthofix.
16. PrimaLIF TM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System from OsteoMed.
More Articles on FDA Clearances:
24 Spine Devices Receive FDA 510(k) Clearance in October
13 Spine Devices Receive FDA 510(k) Clearance in September
23 Spine Devices Receive FDA 510(k) Clearance in August
© Copyright ASC COMMUNICATIONS 2015. Interested in LINKING to or REPRINTING this content? View our policies here.
Most Read - Devices & Implants
- 22 minimally invasive spine devices to know
- Smith & Nephew to acquire Blue Belt Technologies: 6 key notes
- Alphatec Spine, LDR, Globus Medical & more — 21 key notes
- Laser Spine Institute establishes clinical trials partnership with Spinal Kinetics, Titan Spine: 6 key notes
- $27.8B by 2022: 6 trends in the U.S. medical device outsourcing market
Top 40 Articles from the Past 6 Months
- 15 things to know about Zimmer Biomet
- Neurosurgeon named in counterfeit spinal implant lawsuit — 5 things to know
- 55 statistics and issues for neurosurgeons and orthopedic spine surgeons — compensation, global device market and more
- 6 spine physicians ranked #1 on Google
- Dr. Aria Sabit pleads guilty to unnecessary spine surgery, faces 11+ years in prison — 5 things to know
- Medtronic pays 8 physicians $1M+: 5 key notes
- Is the Zimmer-Biomet closed merger finally around the corner? 5 things to know
- Another spine surgeon named in "fake implants" lawsuit — This time in Maryland: 5 key notes
- UPMC's Dr. Tanya Hagen dies at age 45
- Medtronic facing product liability lawsuit over Infuse once more: 9 things to know
- Hospitals face 4 lawsuits in connection with unnecessary spine surgeries case — 6 things to know
- Grand jury indicts troubled Texas spine surgeon — 5 key notes
- Patient sues troubled orthopedic surgeon for malpractice — 7 things to know
- 23 statistics for orthopedic surgeons — compensation, net worth & more
- Brigham and Women's Hospital names Dr. James Kang orthopedics chairman: 6 key facts
- 10 trends in the spinal fusion market
- The future of orthopedics: ACOs, bundled payments, gain-sharing & the advantage in change
- Cleveland Clinic standardizes to 2 implant vendors, at least one orthopedic surgeon out
- 22 things to know about Stryker
- 15 things to know about Smith & Nephew
- Spine surgery in a value-based world: Dr. Jed Vanichkachorn on spine bundled payments
- The endless possibilities in spine biologics, artificial disc & outpatient procedures
- Orthopedic surgeon Dr. Michael Reilly's whistleblower lawsuit results in $69M+ penalty for Broward Health — 7 things to know
- Surface technology for spine devices: Key trends & concepts
- Becker's Spine Review Channels
- Hospital employment vs. independent practice: 5 spine surgeons weigh in
- 5 things to know about physician assistant pay
- Current annual & hourly salary rates for orthopedic surgeons: 8 statistics
- 7 trends in the $850M bone graft substitute market
- Surgeon Scorecard — Good or bad for spine? 5 things to know
- Did this orthopedic surgeon let his PA perform surgery? Dr. Munir Uwaydah faces conspiracy, $150M fraud & aggravated mayhem charges: 6 key notes
- 3rd spinal cord injury patient with InVivo's Neuro-Spinal Scaffold improving: 5 key updates
- Former OtisMed CEO gets 2 years in prison in knee device scandal — 5 key notes
- Dr. Sang-Ho Lee awarded Parviz Kambin award for endoscopic spine surgery at NASS meeting: 5 highlights
- 15 things to know about physician shortages
- Renowned orthopedic surgeon Dr. Robert Small dies in bicycle crash — 4 things to know
- NYU Langone welcomes Dr. R. Shay Bess as head of adult spinal deformity: 7 key notes
- Zimmer-Biomet $14B merger finally complete — 6 things to know
- Spinal fusion after 10 years: 5 key notes on adjacent segment disease
- Physician stabbed in Virginia leaving clinic — Attacker wanted more pain meds