Paramount IBF 29-TA-3211

GUDID 10889981041724

Intervertebral Body Fusion Implant, 32mm x 11mm x 6 (05-0361-01)

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981041724
• NIH Device Record Key: 9af91b9f-f7e8-455b-a2da-f90a80417941
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paramount IBF
• Version Model Number: 29-TA-3211
• Catalog Number: 29-TA-3211
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: false
• 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(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981041724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103228

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981041724]

Moist Heat or Steam Sterilization

[10889981041724]

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: 2015-09-24

On-Brand Devices [Paramount IBF]

• 10889981041755: Intervertebral Body Fusion Implant, 32mm x 14mm x 6 (05-0364-01)
• 10889981041748: Intervertebral Body Fusion Implant, 32mm x 13mm x 6 (05-0363-01)
• 10889981041731: Intervertebral Body Fusion Implant, 32mm x 12mm x 6 (05-0362-01)
• 10889981041724: Intervertebral Body Fusion Implant, 32mm x 11mm x 6 (05-0361-01)
• 10889981041717: Intervertebral Body Fusion Implant, 32mm x 10mm x 6 (05-0360-01)
• 10889981041700: Intervertebral Body Fusion Implant, 32mm x 9mm x 6 (05-0369-01)
• 10889981041694: Intervertebral Body Fusion Implant, 32mm x 8mm x 6 (05-0368-01)
• 10889981041687: Intervertebral Body Fusion Implant, 32mm x 7mm x 6 (05-0367-01)
• 10889981041670: Intervertebral Body Fusion Implant, 27mm x 14mm x 6 (05-0264-01)
• 10889981041663: Intervertebral Body Fusion Implant, 27mm x 13mm x 6 (05-0263-01)
• 10889981041656: Intervertebral Body Fusion Implant, 27mm x 12mm x 6 (05-0262-01)
• 10889981041649: Intervertebral Body Fusion Implant, 27mm x 11mm x 6 (05-0261-01)
• 10889981041632: Intervertebral Body Fusion Implant, 27mm x 10mm x 6 (05-0260-01)
• 10889981041625: Intervertebral Body Fusion Implant, 27mm x 9mm x 6 (05-0269-01)
• 10889981041618: Intervertebral Body Fusion Implant, 27mm x 8mm x 6 (05-0268-01)
• 10889981041601: Intervertebral Body Fusion Implant, 27mm x 7mm x 6 (05-0267-01)
• 10889981041595: Intervertebral Body Fusion Implant, 32mm x 14mm x 0 (05-0304-01)
• 10889981041588: Intervertebral Body Fusion Implant, 32mm x 13mm x 0 (05-0303-01)
• 10889981041571: Intervertebral Body Fusion Implant, 32mm x 12mm x 0 (05-0302-01)
• 10889981041564: Intervertebral Body Fusion Implant, 32mm x 11mm x 0 (05-0301-01)
• 10889981041557: Intervertebral Body Fusion Implant, 32mm x 10mm x 0 (05-0300-01)
• 10889981041540: Intervertebral Body Fusion Implant, 32mm x 9mm x 0 (05-0309-01)
• 10889981041533: Intervertebral Body Fusion Implant, 32mm x 8mm x 0 (05-0308-01)
• 10889981041526: Intervertebral Body Fusion Implant, 32mm x 7mm x 0 (05-0307-01)
• 10889981041519: Intervertebral Body Fusion Implant, 27mm x 14mm x 0 (05-0204-01)
• 10889981041502: Intervertebral Body Fusion Implant, 27mm x 13mm x 0 (05-0203-01)
• 10889981041496: Intervertebral Body Fusion Implant, 27mm x 12mm x 0 (05-0202-01)
• 10889981041489: Intervertebral Body Fusion Implant, 27mm x 11mm x 0 (05-0201-01)
• 10889981041472: Intervertebral Body Fusion Implant, 27mm x 10mm x 0 (05-0200-01)
• 10889981041465: Intervertebral Body Fusion Implant, 27mm x 9mm x 0 (05-0209-01)
• 10889981041458: Intervertebral Body Fusion Implant, 27mm x 8mm x 0 (05-0208-01)
• 10889981041441: Intervertebral Body Fusion Implant, 27mm x 7mm x 0 (05-0207-01)
• 10889981041434: Intervertebral Body Fusion Implant, 22mm x 14mm x 0 (05-0104-01)
• 10889981041427: Intervertebral Body Fusion Implant, 22mm x 13mm x 0 (05-0103-01)
• 10889981041410: Intervertebral Body Fusion Implant, 22mm x 12mm x 0 (05-0102-01)
• 10889981041403: Intervertebral Body Fusion Implant, 22mm x 11mm x 0 (05-0101-01)
• 10889981041397: Intervertebral Body Fusion Implant, 22mm x 10mm x 0 (05-0100-01)
• 10889981041380: Intervertebral Body Fusion Implant, 22mm x 9mm x 0 (05-0109-01)
• 10889981041373: Intervertebral Body Fusion Implant, 22mm x 8mm x 0 (05-0108-01)
• 10889981041366: Intervertebral Body Fusion Implant, 22mm x 7mm x 0 (05-0107-01)
• 10889981041359: Fixed Trial; 32x14 (05-3524)
• 10889981041342: Fixed Trial; 32x13 (05-3523)
• 10889981041335: Fixed Trial; 32x12 (05-3522)
• 10889981041328: Fixed Trial; 32x11 (05-3521)
• 10889981041311: Fixed Trial; 32x10 (05-3520)
• 10889981041304: Fixed Trial; 32x9 (05-3529)
• 10889981041298: Fixed Trial; 32x8 (05-3528)
• 10889981041281: Fixed Trial; 32x7 (05-3527)
• 10889981041274: Fixed Trial; 27x14 (05-3514)
• 10889981041267: Fixed Trial; 27x13 (05-3513)