FDA 510(k) Clearance
-
Regulatory
Life Spine Announces FDA 510(k) Clearance for the PLATEAU®-X Ti Lateral Lumbar Spacer System
August 11, 2020 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
Read More » -
Regulatory
Safe Orthopaedics receives 510k approval from the FDA for the sale of its 2nd Generation of SteriSpineTM PS in the United States
Eragny-sur-Oise, France, August 10th à 6.00 PM CEST – Safe Orthopaedics (FR0013467123 – ALSAF), a company specializing in the design and…
Read More » -
Regulatory
Life Spine Announces FDA 510(k) Clearance for the PLATEAU®-A Ti Anterior Lumbar Spacer System
August 05, 2020 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
Read More » -
Extremities
Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Reduced Size Foot Plating System
WARSAW, IND. (PRWEB) JULY 31, 2020 Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space,…
Read More » -
Recon
![Photo of FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres](https://i1.wp.com/orthospinenews.com/wp-content/uploads/2020/07/1-shoulder.jpg?resize=390%2C220&ssl=1)
FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres
DALLAS, July 20, 2020 /PRNewswire/ — FX received 510k clearances for their TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres. The new addition of TiN coated…
Read More » -
Extremities
Orthofix Receives FDA Clearance and CE Mark for the JuniOrtho Plating System
July 20, 2020 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, today…
Read More » -
Extremities
Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Cannulated Hammertoe System
WARSAW, IND. (PRWEB) JULY 03, 2020 Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space,…
Read More » -
Recon
Engage Surgical Announces FDA 510(k) Clearance And Limited Market Release Of The Cementless Engage™ Partial Knee System
July 1, 2020 ORLANDO, Fla., July 1, 2020 /PRNewswire/ — Engage Surgical, a privately held orthopedic implant company, announces FDA 510(k) clearance of the only…
Read More » -
Regulatory
CoreLink Announces FDA Clearance of F3D-C2 Stand-alone Cervical Spine System
June 30, 2020 ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a leading designer and manufacturer of spinal implant systems, today announced the commercial…
Read More » -
Regulatory
Orthofix Announces FDA Clearance and First Patient Implants of FIREBIRD SI Fusion System for Low Back Pain
June 29, 2020 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, announced the…
Read More » -
Recon
Conformis Announces 510(k) Clearance for iTotal® Identity PS
BILLERICA, Mass., June 22, 2020 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS) today announced 510(k) clearance by the U.S. Food and Drug…
Read More » -
Regulatory
icotec ag Receives Approvals for Two KONG® VBR Spinal Systems Made with BlackArmor® and Ti-iT® in Europe and the US
ALTSTAETTEN, Switzerland, June 18, 2020 /PRNewswire/ — icotec ag announces that the KONG®-TL and the KONG®-C vertebral body replacement systems with the unique Titaniumcoating…
Read More » -
Biologics
SIRAKOSS Receives U.S. FDA 510(k) Clearance for Osteo3 ZP Putty to Catalyse Rapid and Complete Bone Regeneration
Aberdeen, UK, 17 June 2020 – SIRAKOSS Ltd, a developer of nanosynthetic bone graft substitutes, announced today that it has received…
Read More » -
Regulatory
MiRus™ Announces First Clinical Use of the MiRus™ 3DR™ Printed Lumbar Interbody Fusion System
ATLANTA, June 11, 2020 /PRNewswire/ — MiRus is pleased to announce that it received FDA 510(k) clearance for its 3DR™ (Randomized) Printed…
Read More » -
Regulatory
Meditech Spine Receives FDA Clearance for its CURE™ OPEL-L (S) system
ATLANTA, June 1, 2020 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the CURE™ Opel-L (S) system, a new lumbar…
Read More »