Spinal Fusion Cage System TPU0-359B

GUDID 08800033338628

4CIS® Torrey Pines PEEK TLIF Cage 0, 35x9x11mm

SOLCO BIOMEDICAL CO.,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08800033338628
• NIH Device Record Key: 1a6105e9-b428-41c0-874f-09f1d33e5f5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal Fusion Cage System
• Version Model Number: TPU0-359B
• Catalog Number: TPU0-359B
• Company DUNS: 687844241
• Company Name: SOLCO BIOMEDICAL CO.,LTD.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800033338628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190563

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

[08800033338628]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-03
• Device Publish Date: 2020-03-26

On-Brand Devices [Spinal Fusion Cage System]

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• 08806373578991: 4CIS® Augusta PEEK ALIF Cage 12, 28x22x20mm
• 08800033343462: 4CIS® Augusta PEEK ALIF Cage 20, 36x26x20mm
• 08800033343455: 4CIS® Augusta PEEK ALIF Cage 20, 36x26x18mm
• 08800033343448: 4CIS® Augusta PEEK ALIF Cage 20, 36x26x16mm
• 08800033343431: 4CIS® Augusta PEEK ALIF Cage 20, 36x26x14mm
• 08800033343424: 4CIS® Augusta PEEK ALIF Cage 20, 36x26x12mm
• 08800033343356: 4CIS® Augusta PEEK ALIF Cage 20, 28x22x18mm
• 08800033343349: 4CIS® Augusta PEEK ALIF Cage 20, 28x22x16mm
• 08800033343332: 4CIS® Augusta PEEK ALIF Cage 20, 28x22x14mm
• 08800033343325: 4CIS® Augusta PEEK ALIF Cage 20, 28x22x12mm
• 08800033343318: 4CIS® Augusta PEEK ALIF Cage 20, 28x22x10mm
• 08800033343301: 4CIS® Augusta PEEK ALIF Cage 12, 36x26x20mm
• 08800033343295: 4CIS® Augusta PEEK ALIF Cage 12, 36x26x18mm
• 08800033343288: 4CIS® Augusta PEEK ALIF Cage 12, 36x26x16mm
• 08800033343271: 4CIS® Augusta PEEK ALIF Cage 12, 36x26x14mm
• 08800033343264: 4CIS® Augusta PEEK ALIF Cage 12, 36x26x12mm
• 08800033343257: 4CIS® Augusta PEEK ALIF Cage 12, 36x26x10mm
• 08800033343172: 4CIS® Augusta PEEK ALIF Cage 12, 28x22x18mm
• 08800033343165: 4CIS® Augusta PEEK ALIF Cage 12, 28x22x16mm
• 08800033343158: 4CIS® Augusta PEEK ALIF Cage 12, 28x22x14mm
• 08800033343141: 4CIS® Augusta PEEK ALIF Cage 12, 28x22x12mm
• 08800033343134: 4CIS® Augusta PEEK ALIF Cage 12, 28x22x10mm
• 08800033343127: 4CIS® Augusta PEEK ALIF Cage 6, 36x26x20mm
• 08800033343110: 4CIS® Augusta PEEK ALIF Cage 6, 36x26x18mm
• 08800033343103: 4CIS® Augusta PEEK ALIF Cage 6, 36x26x16mm
• 08800033343097: 4CIS® Augusta PEEK ALIF Cage 6, 36x26x14mm
• 08800033343080: 4CIS® Augusta PEEK ALIF Cage 6, 36x26x12mm
• 08800033343073: 4CIS® Augusta PEEK ALIF Cage 6, 36x26x10mm
• 08800033343004: 4CIS® Augusta PEEK ALIF Cage 6, 28x22x20mm
• 08800033342991: 4CIS® Augusta PEEK ALIF Cage 6, 28x22x18mm
• 08800033342984: 4CIS® Augusta PEEK ALIF Cage 6, 28x22x16mm
• 08800033342977: 4CIS® Augusta PEEK ALIF Cage 6, 28x22x14mm
• 08800033342960: 4CIS® Augusta PEEK ALIF Cage 6, 28x22x12mm
• 08800033342953: 4CIS® Augusta PEEK ALIF Cage 6, 28x22x10mm
• 08800033337638: 4CIS® PEEK PLIF Cage 4 , 40x12x14mm
• 08800033337621: 4CIS® PEEK PLIF Cage 4 , 40x12x13mm
• 08800033337614: 4CIS® PEEK PLIF Cage 4 , 40x12x12mm
• 08800033337607: 4CIS® PEEK PLIF Cage 4 , 40x12x11mm
• 08800033337591: 4CIS® PEEK PLIF Cage 4 , 40x12x10mm
• 08800033337584: 4CIS® PEEK PLIF Cage 0 , 40x11x7mm
• 08800033337577: 4CIS® PEEK PLIF Cage 0 , 32x11x7mm
• 08800033337560: 4CIS® PEEK PLIF Cage 0 , 28x11x7mm
• 08800033337553: 4CIS® PEEK PLIF Cage 0 , 25x11x7mm
• 08800033337546: 4CIS® Pebble Beach PEEK PLIF Cage 8, 40x11x14mm
• 08800033337539: 4CIS® Pebble Beach PEEK PLIF Cage 8, 40x11x13mm
• 08800033337522: 4CIS® Pebble Beach PEEK PLIF Cage 8, 40x11x12mm
• 08800033337515: 4CIS® Pebble Beach PEEK PLIF Cage 8, 40x11x11mm
• 08800033337508: 4CIS® Pebble Beach PEEK PLIF Cage 8, 36x11x14mm