Regulatory

GLOBUS MEDICAL ANNOUNCES FDA 510(K) CLEARANCE FOR EXCELSIUS GPS™
Regulatory Robotics Top Stories

GLOBUS MEDICAL ANNOUNCES FDA 510(K) CLEARANCE FOR EXCELSIUS GPS™

AUDUBON, Pa., Aug. 17, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that the Excelsius GPS™, a revolutionary robotic guidance and navigation system, has been 510(k) cleared by the U.S. Food and Drug Administration. This platform technology supports minimally invasive and open orthopedic […]

Stryker’s Spine Division Receives FDA Clearance for Serrato Pedicle Screw
Regulatory Spine Top Stories

Stryker’s Spine Division Receives FDA Clearance for Serrato Pedicle Screw

August 16, 2017 ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Serrato™ Pedicle Screw, intended for use in the non-cervical spine as part of the company’s successful Xia® 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration. Serrato Pedicle Screws feature enhanced serrated cutting flutes, […]

Camber Spine Technologies Announces FDA Clearance And National Launch Of SPIRA™ Open Matrix ALIF
Regulatory Spine

Camber Spine Technologies Announces FDA Clearance And National Launch Of SPIRA™ Open Matrix ALIF

WAYNE, Pa., Aug. 15, 2017 /PRNewswire/ — Camber Spine Technologies announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™ Open Matrix ALIF device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology.  This clearance marks Camber’s […]

Renovis® Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems
Regulatory Spine Top Stories

Renovis® Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems

REDLANDS, Calif., Aug. 11, 2017 /PRNewswire/ — Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody fusion systems. These systems feature implants for direct posterior (PLIF) or transforaminal (TLIF) approaches in both straight and […]

Expanding Orthopedics Inc. Granted Two Additional US Patents in the Expandable Interbody Domain
Regulatory Spine

Expanding Orthopedics Inc. Granted Two Additional US Patents in the Expandable Interbody Domain

OR-AKIVA, Israel, August 14, 2017 /PRNewswire/ — Expanding Orthopedics Inc. (EOI), a medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that it has been granted two additional US Patents by the USPTO covering its unique and diverse expandable cage technology, strengthening its position in […]

Xtant Medical Receives FDA Clearance for Calix-C Cervical Interbody Line Extension and Expanded Indications
Regulatory Spine Top Stories

Xtant Medical Receives FDA Clearance for Calix-C Cervical Interbody Line Extension and Expanded Indications

BELGRADE, Mont., Aug. 09, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Calix-C family of cervical interbody cages.  The […]

In2Bones USA Announces FDA Clearance on Two Key Implant Systems
Extremities Regulatory

In2Bones USA Announces FDA Clearance on Two Key Implant Systems

August 08, 2017 MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for its new Fracture and Correction System. The System will be marketed under the 5MS™ Fracture Repair System and the CoLag™ Locking Compression Screw System brand names. The 5MS Fracture […]

Mainstay Medical’s ReActiv8-B Clinical Trial Passes Mid-point
Neuro Regulatory

Mainstay Medical’s ReActiv8-B Clinical Trial Passes Mid-point

August 03, 2017 Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that over half the required […]

CTL Medical Secures FDA Clearance for Titanium Cage Device
Regulatory Spine Top Stories

CTL Medical Secures FDA Clearance for Titanium Cage Device

DALLAS, TX – 07/25/2017 (PRESS RELEASE JET) — CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has secured FDA clearance to market its new MATISSE™ Titanium ACIF Cage implant with TiCro™ surface, used in the practice of spine fusion surgery. The MATISSE™ Titanium ACIF Cage with CTL Medical’s […]

MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA
Regulatory Top Stories

MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA

WASHINGTON, July 26, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization to the medical device industry, today announced that it has authored a new white paper, “The Potential FDA Impact of the 2018 Presidential Budget Request”. Following the release of the 2018 budget request, […]

Vertera Spine Announces FDA Clearance of COALESCE™ porous PEEK Lumbar Interbody Fusion Device
Regulatory Spine Top Stories

Vertera Spine Announces FDA Clearance of COALESCE™ porous PEEK Lumbar Interbody Fusion Device

ATLANTA, July 25, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the COALESCE™ Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. COALESCE features Vertera Spine’s novel proprietary […]

Providence Medical Technology Announces Regulatory Approval From Australian (TGA) For its DTRAX® Line
Regulatory Spine

Providence Medical Technology Announces Regulatory Approval From Australian (TGA) For its DTRAX® Line

WALNUT CREEK, Calif., July 25, 2017 /PRNewswire/ — Providence Medical Technology, Inc., a developer of innovative cervical spine technology today announced regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DTRAX line of instruments and implants used in tissue-sparing posterior cervical fusion. The TGA approval covers GL-DTRAX Spinal System, GL-DTRAX […]

SpinalCyte acquires a new Japanese patent
Regulatory

SpinalCyte acquires a new Japanese patent

July 21, 2017 Houston – ( BUSINESS WIRE ) – SpinalCyte, LLC, a tissue engineering technology company that is based in Texas and focuses on the regeneration of the disc nucleus pulposus using human skin fibroblasts , today announced that Japan Patent 6151006 ” Method and composition for cartilage repair using body bioreactor “announced the registration. The technique […]