Stainless Steel 25-15-9545

GUDID 10889981024772

D-Planar Screw, 9.50mm x 45mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981024772
• NIH Device Record Key: b74ce1de-1f4a-439d-9076-0cd73ed63210
• Commercial Distribution Discontinuation: 2016-09-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Stainless Steel
• Version Model Number: 25-15-9545
• Catalog Number: 25-15-9545
• 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	10889981024772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100970

FDA Product Code

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

Sterilization

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

[10889981024772]

Moist Heat or Steam Sterilization

[10889981024772]

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 [Stainless Steel]

• 10889981140090: Stainless Locking Screws Instruments
• 10889981114893: Cross Connector Sterilization Case
• 10889981114886: Locking Screw Sterilization Case
• 10889981114879: Rod Sterilization Case
• 10889981114862: Hook Sterilization Case
• 10889981114855: Sterilization Case, Deformity Pedicle Screws
• 10889981114848: Poly Screw Sterilization Case
• 10889981114831: Fixed Screw Sterilization Case
• 10889981114824: Pedicle Prep Sterilization Case
• 10889981114817: T-25 Screw Driver
• 10889981114800: Rotation Block
• 10889981114794: Gearteeth Coronal Rod Bender, Right
• 10889981114787: Gearteeth Coronal Rod Bender, Left
• 10889981114770: Sagittal Deformity Rod Bender, Right
• 10889981114763: Sagittal Deformity Rod Bender, Left
• 10889981114756: Rod Guided Hook Impactor
• 10889981114749: Offset Hook/Screw Holder
• 10889981114732: In-Line Hook/Screw Holder
• 10889981114725: Hook Impactor
• 10889981114718: Double Action Rod Gripper
• 10889981114701: Rod Pusher
• 10889981114695: Cross Connector Gage
• 10889981114688: Cross Connector Bender
• 10889981114671: Cross Connector Cam Driver
• 10889981114664: Rod / Cross Connector Holder
• 10889981114640: Screw Sizing Block
• 10889981114633: Rocker
• 10889981114626: Locking Screw Inserter - T-Handle
• 10889981114619: Kerrison Persuader
• 10889981114602: Locking Screw Final Driver
• 10889981114596: Counter Torque Instrument
• 10889981114589: Fixed Screw/Hook Inserter
• 10889981114572: Locking Screw Guide Tube
• 10889981114565: Polyaxial Screw Inserter (Standard)
• 10889981114558: Polyaxial Screw Inserter (Q style)
• 10889981114541: T-25 Screw Driver, T-Handle
• 10889981114534: Screw Seat Adjuster
• 10889981114527: T-40 Screw Driver, T-Handle
• 10889981114510: Locking Screw Inserter
• 10889981114503: Torque Limiting Handle - 125 in.-lb.
• 10889981114046: Malleable Rod, 400mm
• 10889981028800: Fixed Cross Connector, 60mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028794: Fixed Cross Connector, 56mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028787: Fixed Cross Connector, 52mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028770: Fixed Cross Connector, 48mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028763: Fixed Cross Connector, 44mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028756: Fixed Cross Connector, 40mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028749: Fixed Cross Connector, 38mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028732: Fixed Cross Connector, 36mm. The Stainless Steel Spinal System consists of a variety of types an
• 10889981028725: Fixed Cross Connector, 34mm. The Stainless Steel Spinal System consists of a variety of types an