CapSure® Spine System 10-3236

GUDID 10840642129908

PS3 Tap, 7.0mm, NAV-M

Spine Wave, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10840642129908
• NIH Device Record Key: bf253046-e850-41ab-bb46-d1401bdb00fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CapSure® Spine System
• Version Model Number: 10-3236
• Catalog Number: 10-3236
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• 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: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642129908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181596

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

[10840642129908]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-01-03

On-Brand Devices [CapSure® Spine System]

• 10840642104929: PS2 Screw 5.5mm x 55mm
• 10840642104905: PS2 Screw 5.5mm x 50mm
• 10840642104882: PS2 Screw 5.5mm x 45mm
• 10840642104868: PS2 Screw 5.5mm x 40mm
• 10840642104844: PS2 Screw 5.5mm x 35mm
• 10840642104820: PS2 Screw 5.5mm x 30mm
• 10840642104806: PS2 Screw 5.5mm x 25mm
• 10840642105216: PS2 Screw 7.5mm x 60mm
• 10840642105193: PS2 Screw 7.5mm x 55mm
• 10840642105179: PS2 Screw 7.5mm x 50mm
• 10840642105155: PS2 Screw 7.5mm x 45mm
• 10840642105131: PS2 Screw 7.5mm x 40mm
• 10840642105117: PS2 Screw 7.5mm x 35mm
• 10840642105094: PS2 Screw 7.5mm x 30mm
• 10840642105049: PS2 Screw 6.5mm x 55mm
• 10840642105025: PS2 Screw 6.5mm x 50mm
• 10840642105001: PS2 Screw 6.5mm x 45mm
• 10840642104981: PS2 Screw 6.5mm x 40mm
• 10840642104967: PS2 Screw 6.5mm x 35mm
• 10840642104943: PS2 Screw 6.5mm x 30mm
• 10840642129922: PS3 Tap, 8.0mm, NAV-M
• 10840642129915: PS3 Tap, 7.5mm, NAV-M
• 10840642129908: PS3 Tap, 7.0mm, NAV-M
• 10840642129892: PS3 Tap, 6.5mm, NAV-M
• 10840642129885: PS3 Tap, 6.0mm, NAV-M
• 10840642129878: PS3 Tap, 5.5mm, NAV-M
• 10840642129861: PS3 Tap, 5.0mm, NAV-M
• 10840642129854: PS3 Tap, 4.5mm, NAV-M
• 10840642129847: PS3 Tap, 4.0mm, NAV-M
• 10840642129830: PS3 Screwdriver, NAV-M
• 10840642129823: PS3 Pedicle Probe, Straight, NAV-M
• 10840642129816: PS3 Safety Awl, NAV-M
• 10840642104516: Rod Straight 5.5 x 300mm
• 10840642104509: Rod Straight 5.5 x 95mm
• 10840642104493: Rod Straight 5.5 x 90mm
• 10840642104486: Rod Straight 5.5 x 85mm
• 10840642104479: Rod Straight 5.5 x 80mm
• 10840642104462: Rod Straight 5.5 x 75mm
• 10840642104455: Rod Straight 5.5 x 70mm
• 10840642104448: Rod Straight 5.5 x 65mm
• 10840642104431: Rod Straight 5.5 x 60mm
• 10840642104424: Rod Straight 5.5 x 55mm
• 10840642104417: Rod Straight 5.5 x 50mm
• 10840642104400: Rod Straight 5.5 x 45mm
• 10840642104394: Rod Straight 5.5 x 40mm
• 10840642104387: Rod Straight 5.5 x 35mm
• 10840642104370: Rod Straight 5.5 x 30mm
• 10840642104363: Rod Straight 5.5 x 140mm
• 10840642104356: Rod Straight 5.5 x 130mm
• 10840642104349: Rod Straight 5.5 x 120mm