NewPort 63-7580

GUDID 10889981006969

Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 80mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981006969
• NIH Device Record Key: a0852043-4593-4703-b721-fc73b6a74910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NewPort
• Version Model Number: 63-7580
• Catalog Number: 63-7580
• 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
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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	10889981006969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083089

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

Moist Heat or Steam Sterilization

[10889981006969]

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: 2015-09-28

On-Brand Devices [NewPort]

• 10889983163066: NewPort 2 Implant
• 10889981136277: NewPort 9.5mm Implant Caddy
• 10889981136260: NewPort 4.75mm Implant Caddy
• 10889981125677: NewPort Double Lead Screw, 9.5 x 60mm (4mm Hex)
• 10889981125660: NewPort Double Lead Screw, 9.5 x 55mm (4mm Hex)
• 10889981125653: NewPort Double Lead Screw, 9.5 x 50mm (4mm Hex)
• 10889981125646: NewPort Double Lead Screw, 9.5 x 45mm (4mm Hex)
• 10889981125639: NewPort Double Lead Screw, 9.5 x 40mm (4mm Hex)
• 10889981125622: NewPort Double Lead Screw, 9.5 x 35mm (4mm Hex)
• 10889981125615: NewPort Double Lead Screw, 8.5 x 60mm (4mm Hex)
• 10889981125608: NewPort Double Lead Screw, 8.5 x 55mm (4mm Hex)
• 10889981125592: NewPort Double Lead Screw, 8.5 x 50mm (4mm Hex)
• 10889981125585: NewPort Double Lead Screw, 8.5 x 45mm (4mm Hex)
• 10889981125578: NewPort Double Lead Screw, 8.5 x 40mm (4mm Hex)
• 10889981125561: NewPort Double Lead Screw, 8.5 x 35mm (4mm Hex)
• 10889981125554: NewPort Double Lead Screw, 4.75 x 50mm (4mm Hex)
• 10889981125547: NewPort Double Lead Screw, 4.75 x 45mm (4mm Hex)
• 10889981125530: NewPort Double Lead Screw, 4.75 x 40mm (4mm Hex)
• 10889981125523: NewPort Double Lead Screw, 4.75 x 35mm (4mm Hex)
• 10889981125516: NewPort Double Lead Screw, 4.75 x 30mm (4mm Hex)
• 10889981120306: NewPort Double Lead Screw, DIA 5.5 x 60mm
• 10889981120283: NewPort MIS Rod 2, 85mm
• 10889981120276: Newport MIS Rod 2, 30mm
• 10889981120269: 85mm NewPort MIS Rod
• 10889981120252: 30mm NewPort MIS Rod
• 10889981120245: 85mm NewPort MIS Cap/Rod Combo 2
• 10889981120238: 30mm NewPort MIS Cap/Rod Combo 2
• 10889981120214: 65mm NewPort MIS Cap/Rod Combo
• 10889981120207: 55mm NewPort MIS Cap/Rod Combo
• 10889981120191: 30mm NewPort MIS Cap/Rod Combo
• 10889981119164: NewPort 2 Instrument
• 10889981119140: MIS Posterior Site Prep Instrument
• 10889981086480: NewPort Cap Remover
• 10889981086473: Extended Bullet Nose Saddle Driver Shaft
• 10889981086466: Bullet Nose Saddle Driver Shaft
• 10889981086459: Driver Over-Sleeve, Plastic
• 10889981086442: Driver Over-Sleeve, SS
• 10889981086435: Bullet Nose Qwik Driver Sleeve
• 10889981086428: Cannulated 3mm Pedicle Driver
• 10889981086411: Qwik Driver Shaft
• 10889981086398: Ozat Hex Driver Shaft
• 10889981086381: Hex Saddle Driver Shaft
• 10889981086374: Offset Targeting Stylet 7mm
• 10889981086367: Offset Targeting Stylet 6mm
• 10889981086350: Offset Targeting Stylet 5mm
• 10889981086343: Offset Targeting Stylet 4mm
• 10889981086336: Offset Targeting Stylet 3mm
• 10889981086329: Extended Dilator 22mm, Light Port
• 10889981086312: Extended Dilator 18mm, Light Port
• 10889981086299: Extended Cannulated Straight Thoracic Probe