{"publicDeviceRecordKey":"cd38eb83-9ddd-44cb-85d3-4b9924f00716","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2020-12-09T00:00:00.000Z","devicePublishDate":"2016-09-17T00:00:00.000Z","deviceCommDistributionEndDate":"2020-09-21T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M682110000140","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ENDOSKELETON Posterior DPK","versionModelNumber":"1100-0014","catalogNumber":"1100-0014","dunsNumber":"623316978","companyName":"TITAN SPINE, LLC","deviceCount":1,"deviceDescription":"Straight, Bayonet, Ring Curette, 7mm","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(262)242-7801","phoneExtension":null,"email":"productinfo@titanspine.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31335","gmdnPTName":"Bone curette, reusable","gmdnPTDefinition":"A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXH","productCodeName":"ORTHOPEDIC MANUAL SURGICAL INSTRUMENT"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"15"},"sizeText":null,"sizeString":"Length: 15 Inch"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Disc Prep Kit, Bayonet Ring Curette, Straight, 7mm"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}