SmartLOX Cervical Plate System

GUDID M739CP400170

17mm Drill Bit

CAPTIVA SPINE, INC.

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• Primary Device ID: M739CP400170
• NIH Device Record Key: ec7d518e-1110-474e-843d-697215cb617d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartLOX Cervical Plate System
• Version Model Number: CP40017
• Company DUNS: 836975784
• Company Name: CAPTIVA SPINE, 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: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M739CP400170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141332

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

[M739CP400170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [SmartLOX Cervical Plate System]

• M739CP502100: Plate Bender
• M739CP502000: Caliper 100mm
• M739CP501900: Pin Inserter
• M739CP501800: Cervical Plate Holder
• M739CP501400: Drill Handle With A/O Connect
• M739CP501200: Screwdriver With Handle
• M739CP501000: Bone Awl (retracting)
• M739CP400180: 18mm Drill Bit
• M739CP400170: 17mm Drill Bit
• M739CP400160: 16mm Drill Bit
• M739CP400150: 15mm Drill Bit
• M739CP400140: 14mm Drill Bit
• M739CP400130: 13mm Drill Bit
• M739CP400120: 12mm Drill Bit
• M739CP400110: 11mm Drill Bit
• M739CP400010: Temporary Fixation Pin
• M7393030010000: Locking Screwdriver
• M7391349901040: RLC Bone Awl Sleeve
• M7391334000180: 18mm Drill Bit Spade Tip
• M7391334000170: 17mm Drill Bit Spade Tip
• M7391334000160: 16mm Drill Bit Spade Tip
• M7391334000150: 15mm Drill Bit Spade Tip
• M7391334000140: 14mm Drill Bit Spade Tip
• M7391334000130: 13mm Drill Bit Spade Tip
• M7391334000120: 12mm Drill Bit Spade Tip
• M7391334000110: 11mm Drill Bit Spade Tip
• M7391334010180: MULTI-USE DRILL BIT 18mm-SPADE TIP
• M7391334010170: MULTI-USE DRILL BIT 17mm-SPADE TIP
• M7391334010160: MULTI-USE DRILL BIT 16mm-SPADE TIP
• M7391334010150: MULTI-USE DRILL BIT 15mm-SPADE TIP
• M7391334010140: MULTI-USE DRILL BIT 14mm-SPADE TIP
• M7391334010130: MULTI-USE DRILL BIT 13mm-SPADE TIP
• M7391334010120: MULTI-USE DRILL BIT 12mm-SPADE TIP
• M7391334010110: MULTI-USE DRILL BIT 11mm-SPADE TIP