Back to Results
First PageMeta Content
Food and Drug Administration / Spinal fusion / Implants / Prosthetics / Spondylolisthesis / Medical device / Vertebral fixation / Degenerative disc disease / Federal Food / Drug / and Cosmetic Act / Medicine / Neurosurgery / Orthopedic surgery


K123 993 Page 1 of[removed]k) Summary Aiphatec SOLUS® Anterior Lumbar Interbody Fusion System 5 10(k) Summary
Add to Reading List

Document Date: 2013-04-11 12:53:22

Open Document

File Size: 139,22 KB

Share Result on Facebook

Company

Alphatec Spine Inc. / K123993 Trade / Aiphatec Spine Incorporated / /

Country

United States / /

Facility

New Hampshire Avenue Document Control Center / /

/

IndustryTerm

stainless steel / announcements concerning your device / body fusion device / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / /

MedicalCondition

degenerative disc disease / spondylolisthesis / back pain / I spondylolisthesis / lordosis / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Center for Devices and Radiological Health / office of Compliance / Anton E. DfiiitiZ-v.;PhD Division / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / office of Surveillance / i.th Mark N. Melkerson Director Division / FDA / Department of Defense / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / /

Person

Trevor J. Denbo / Eri Kl / Mark N. Melkerson / Camino Real Carlsbad / /

/

Position

Regulatory Affairs Specialist / /

Product

FS / /

ProvinceOrState

Maryland / California / /

Technology

radiation / http / /

URL

www.fda.gov/MedicaiDevices/ResourcesforYOLI/industry/defaulthtm / http /

SocialTag