NewPort™ 60-0513

GUDID 10889981030674

Newport MIS Rod 2, 130mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981030674
• NIH Device Record Key: 16818b3d-af39-4323-995a-b142f92dc1d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NewPort™
• Version Model Number: 60-0513
• Catalog Number: 60-0513
• 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
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981030674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083089
• Premarket Notification: K161535

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[10889981030674]

Moist Heat or Steam Sterilization

[10889981030674]

Moist Heat or Steam Sterilization

[10889981030674]

Moist Heat or Steam Sterilization

[10889981030674]

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 [NewPort™]

• 10889981030780: Newport MIS Rod 2, 90mm
• 10889981030773: Newport MIS Rod 2, 80mm
• 10889981030766: Newport MIS Rod 2, 75mm
• 10889981030759: Newport MIS Rod 2, 70mm
• 10889981030742: Newport MIS Rod 2, 65mm
• 10889981030735: Newport MIS Rod 2, 60mm
• 10889981030728: Newport MIS Rod 2, 55mm
• 10889981030711: Newport MIS Rod 2, 50mm
• 10889981030704: Newport MIS Rod 2, 45mm
• 10889981030698: Newport MIS Rod 2, 40mm
• 10889981030681: Newport MIS Rod 2, 35mm
• 10889981030674: Newport MIS Rod 2, 130mm
• 10889981030667: Newport MIS Rod 2, 120mm
• 10889981030650: Newport MIS Rod 2, 110mm
• 10889981030643: Newport MIS Rod 2, 100mm
• 10889981030636: 90mm NewPort MIS Rod
• 10889981030629: 80mm NewPort MIS Rod
• 10889981030612: 75mm NewPort MIS Rod
• 10889981030605: 70mm NewPort MIS Rod
• 10889981030599: 65mm NewPort MIS Rod
• 10889981030582: 60mm NewPort MIS Rod
• 10889981030575: 55mm NewPort MIS Rod
• 10889981030568: 50mm NewPort MIS Rod
• 10889981030551: 45mm NewPort MIS Rod
• 10889981030544: 40mm NewPort MIS Rod
• 10889981030537: 35mm NewPort MIS Rod
• 10889981030520: 110mm NewPort MIS Rod
• 10889981030513: 100mm NewPort MIS Rod
• 10889981030506: 90mm NewPort MIS Cap/Rod Combo 2
• 10889981030490: 80mm NewPort MIS Cap/Rod Combo 2
• 10889981030483: 75mm NewPort MIS Cap/Rod Combo 2
• 10889981030476: 70mm NewPort MIS Cap/Rod Combo 2
• 10889981030469: 65mm NewPort MIS Cap/Rod Combo 2
• 10889981030452: 60mm NewPort MIS Cap/Rod Combo 2
• 10889981030445: 55mm NewPort MIS Cap/Rod Combo 2
• 10889981030438: 50mm NewPort MIS Cap/Rod Combo 2
• 10889981030421: 45mm NewPort MIS Cap/Rod Combo 2
• 10889981030414: 40mm NewPort MIS Cap/ Rod Combo 2
• 10889981030407: 35mm NewPort MIS Cap/Rod Combo 2
• 10889981030391: 110mm NewPort MIS Cap/Rod Combo 2
• 10889981030384: 100mm NewPort MIS Cap/Rod Combo 2
• 10889981030377: 45mm NewPort MIS Cap/Rod Combo
• 10889981030360: Universal Locking Cap
• 10889981030353: 70mm NewPort MIS Cap/Rod Combo
• 10889981030346: 60mm NewPort MIS Cap/Rod Combo
• 10889981030339: 50mm NewPort MIS Cap/Rod Combo
• 10889981030322: 40mm NewPort MIS Cap/Rod Combo
• 10889981030315: 35mm NewPort MIS Cap/Rod Combo
• 10889981030308: NewPort MIS Cap
• 10889981028220: NewPort Rod Implant. The NewPort system contains cannulated polyaxial screws, locking caps and r