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Pedicle
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#	Item
11	510(k) Summary for the ReForm Pedicle Screw System AG 821 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-09-10 10:28:37 Food and Drug Administration Orthopedic surgery Implants Vertebral fixation Spondylolisthesis Scoliosis Human vertebral column Medical device Kyphosis Medicine Neurosurgery Food law
12	K130632 ::page 1 of[removed]k) SUMMARY Submitter Contacts Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-06-10 14:13:25 Technology Food law Pharmaceutical industry Medical device Medical equipment Medical technology Premarket approval Pedicle Spondylolisthesis Medicine Health Food and Drug Administration
13	Zimmer Spi ne[removed]k)- Sequoia® Pedicle Screw System- Section[removed]k) Sum mary 510(k) SUMMARY Zimmer Spine Sequoia®l Pedicle Screw System including SpeedL-ink 11 A Transverse Connector System Date of Summary Prepa Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-10-09 09:32:53 Vertebral column Neurosurgery Orthopedic surgery Implants Prosthetics Vertebral fixation Spondylolisthesis Scoliosis Degenerative disc disease Medicine Anatomy Surgery
14	BAXANOO~ K[removed]page I of 2 SURGICAL Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-05-07 12:36:26 Vertebral column Food and Drug Administration Food law Vertebral fixation Spinal fusion Medical device Spondylolisthesis Pedicle Scoliosis Medicine Neurosurgery Orthopedic surgery
15	Species of Concern Inarticulated brachiopod NOAA National Marine Fisheries Service Add to Reading List Source URL: www.nmfs.noaa.gov Language: English - Date: 2007-05-22 15:35:18 Taxonomy Lingula reevii Lingula Lophophore Pedicle Species of Concern Bivalvia Lingulata Brachiopods Zoology Biology
16	EXECUTIVE SUMMARY Reclassification Petition: Lateral Mass and Pedicle Screws – Cervical Spine Uses TITLE: RECLASSIFICATION PETITION: Add to Reading List Source URL: www.fda.gov Language: English Neurosurgery Orthopedic surgery Implants Spinal fusion Skeletal system Vertebral fixation Spondylolisthesis Cervical vertebrae Degenerative disc disease Medicine Anatomy Vertebral column
17	Classification of Posterior Cervical Screws Including Pedicle and Lateral Mass Screws Meeting of Orthopaedic and Rehabilitation Devices Panel Gaithersburg, MD September 21, 2012 Add to Reading List Source URL: www.fda.gov Language: English Skeletal system Vertebral column Cervical vertebrae Screw Human vertebral column Pedicle Anatomy Osteology Human anatomy
18 $Vertebral column / Skeletal system / Cervical vertebrae / Human vertebral column / Bone fracture / Spine / The Spine Journal / Orthopedic surgery / Medicine / Anatomy / Osteology$	Lateral Mass and Pedicle Screws Fixation of Cervical Spine Add to Reading List Source URL: www.fda.gov Language: English Vertebral column Skeletal system Cervical vertebrae Human vertebral column Bone fracture Spine The Spine Journal Orthopedic surgery Medicine Anatomy Osteology
19	Classification Discussion: Pedicle Screw Spinal Systems (Certain Uses - Class III Indications for Use) Meeting of Orthopaedic and Rehabilitation Devices Panel Gaithersburg, MD May 22, 2013 Add to Reading List Source URL: www.fda.gov Language: English Health Spondylolisthesis Scoliosis Pedicle Degenerative disc disease Vertebral column Medicine Anatomy
20	FDA Draft Questions May 22, 2013 Meeting of the Orthopaedic and Rehabilitation Devices Panel of Medical Devices Advisory Committee Pedicle Screw Spinal Systems (for certain indications) Please refer to the Regulatory Ref Add to Reading List Source URL: www.fda.gov Language: English Neurosurgery Orthopedic surgery Spondylolisthesis Spinal disc herniation Scoliosis Degenerative disc disease Spondylolysis Laminectomy Medical device Medicine Vertebral column Health

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