TOPS™ - 21 L

GUDID 07290014064003

The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.

PREMIA SPINE LTD

Posterior lumbar spine prosthesis

• Primary Device ID: 07290014064003
• NIH Device Record Key: 724b421f-7222-4971-af84-0f2122cea11e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOPS™ - 21 L
• Version Model Number: 82643
• Company DUNS: 649220779
• Company Name: PREMIA SPINE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014064003 [Primary]

FDA Product Code

• QWK: Prosthesis, Posterior Spinal Elements

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: 2023-11-09
• Device Publish Date: 2023-11-01

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• 07290115935271 - PER System 75: 2024-10-18 PER System 75
• 07290115935332 - PER System 50: 2024-10-18 PER System 50
• 07290115935561 - Distractor: 2024-10-18
• 07290115931808 - Ring Nut Inserter: 2024-10-09
• 07290115932485 - Ring Nut Loading Base: 2024-10-09
• 07290115932515 - Versalink Nut Counter Torque: 2024-10-09
• 07290115932553 - VersaLink Bender: 2024-10-09