primaLOK SP

GUDID 00813210021754

primaLOK SP 12mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.

WENZEL SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 00813210021754
• NIH Device Record Key: c17b112b-7d12-48ee-b1dc-63c2413d055e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primaLOK SP
• Version Model Number: 800-0112-00
• Company DUNS: 832543255
• Company Name: WENZEL SPINE, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com

Device Dimensions

• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813210021754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100354

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-12
• Device Publish Date: 2018-06-11

On-Brand Devices [primaLOK SP]

• 00813210022300: Polyaxial Plate Inserter
• 00813210022294: Post Plate Inserter
• 00813210022287: Offset Provisional Locker
• 00813210022270: Inserter Compressor II
• 00813210022263: Removal Tool
• 00813210022256: Lock Ring Compressor
• 00813210022249: Implant Inserter
• 00813210021785: primaLOK SP 28mm Medium Boxless Implant, Sterile
• 00813210021778: primaLOK SP 18mm Implant Assembly, Sterile
• 00813210021761: primaLOK SP 15mm Implant Assembly, Sterile
• 00813210021754: primaLOK SP 12mm Implant Assembly, Sterile
• 00813210021747: primaLOK SP 10mm Implant Assembly, Sterile
• 00813210021730: primaLOK SP 8mm Implant Assembly, Sterile
• 00813210021723: primaLOK SP 6mm Implant Assembly, Sterile
• 00813210021365: Auxiliary Instrument Case
• 00813210021358: Instrument Case