LANCER™ Pedicle Screw Systems

GUDID 00840996135948

LANCER,SCREW,POLYAXIAL,5.0X35

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996135948
• NIH Device Record Key: f56ed81b-9f8a-468c-8c54-4094d8b96373
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANCER™ Pedicle Screw Systems
• Version Model Number: MT30-5035
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996135948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132049

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996135948]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-30

On-Brand Devices [LANCER™ Pedicle Screw Systems]

• 00840996136068: LANCER,SCREW,POLYAXIAL,5.0X110
• 00840996136051: LANCER,SCREW,POLYAXIAL,5.0X100
• 00840996136044: LANCER,SCREW,POLYAXIAL,5.0X90
• 00840996136037: LANCER,SCREW,POLYAXIAL,5.0X80
• 00840996136020: LANCER,SCREW,POLYAXIAL,5.0X75
• 00840996136013: LANCER,SCREW,POLYAXIAL,5.0X70
• 00840996136006: LANCER,SCREW,POLYAXIAL,5.0X65
• 00840996135993: LANCER,SCREW,POLYAXIAL,5.0X60
• 00840996135986: LANCER,SCREW,POLYAXIAL,5.0X55
• 00840996135979: LANCER,SCREW,POLYAXIAL,5.0X50
• 00840996135962: LANCER,SCREW,POLYAXIAL,5.0X45
• 00840996135955: LANCER,SCREW,POLYAXIAL,5.0X40
• 00840996135948: LANCER,SCREW,POLYAXIAL,5.0X35
• 00840996135931: LANCER,SCREW,POLYAXIAL,5.0X30
• 00840996135924: LANCER,SCREW,POLYAXIAL,5.0X25