CONCORDE 287821007

GUDID 10705034305554

CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 9 x 7 x 21/25mm, 0 DEGREES

DEPUY SPINE, LLC

Spinal implant trial

• Primary Device ID: 10705034305554
• NIH Device Record Key: 25c3edbd-2819-4c68-867c-1688b33010af
• Commercial Distribution Discontinuation: 2024-06-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CONCORDE
• Version Model Number: 287821007
• Catalog Number: 287821007
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034305554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110694

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

[10705034305554]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-07-08
• Device Publish Date: 2015-09-24

On-Brand Devices [CONCORDE]

• 10705034219899: CONCORDE SYSTEM INSERTER, BAYONETED 9mm
• 10705034219882: CONCORDE SYSTEM INSERTER, STRAIGHT
• 10705034217208: CONCORDE LS LATERAL CAGE SYSTEM STRAIGHT INSERTER
• 10705034217192: CONCORDE LS LATERAL CAGE SYSTEM OFFSET INSERTER
• 10705034226293: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM RING CURETTE, ANGLED 8mm
• 10705034226286: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM RING CURETTE, STRAIGHT 8mm
• 10705034226262: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM DOWN BITING CURETTE 8mm
• 10705034226248: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM REVERSE CURETTE 8mm
• 10705034226231: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM STRAIGHT CURETTE 8mm
• 10705034226194: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM DOWN BITING CURETTE 6mm
• 10705034226170: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM REVERSE CURETTE 6mm
• 10705034226163: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM STRAIGHT CURETTE 6mm
• 10705034226125: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM DOWN BITING CURETTE 4mm
• 10705034226101: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM REVERSE CURETTE 4mm
• 10705034226095: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM STRAIGHT CURETTE 4mm
• 10705034305165: CONCORDE CURVE CASE
• 10705034220253: CONCORDE SYSTEM REPLACEMENT LID, GREEN
• 10705034220246: CONCORDE SYSTEM UNIVERSAL CADDY
• 10705034220239: CONCORDE SYSTEM IMPLANT CADDY
• 10705034220222: CONCORDE SYSTEM TRIAL CADDY
• 10705034220215: CONCORDE SYSTEM TRAY LID
• 10705034220208: CONCORDE SYSTEM AUXILLARY TRAY
• 10705034220192: CONCORDE SYSTEM IMPLANT HALF TRAY WITH LID
• 10705034220178: CONCORDE SYSTEM CASE AND TRAYS
• 10705034219721: CONCORDE BULLET SPINAL SYSTEM IMPLANT CADDY
• 10705034219714: CONCORDE BULLET SPINAL SYSTEM TRAY
• 10705034219707: CONCORDE BULLET SPINAL SYSTEM TRAY LID
• 10705034226415: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM SUCTION TUBE 13F
• 10705034226408: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM SUCTION TUBE 11F
• 10705034226392: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM SUCTION TUBE - STYLETS
• 10705034226019: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM TISSUE FORCEPS
• 10705034226446: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM COBB ELEVATOR 20mm
• 10705034226439: CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM COBB ELEVATOR 12.7mm
• 10705034219943: CONCORDE SYSTEM RASP, RIGHT ANGLE
• 10705034219936: CONCORDE SYSTEM RASP, LEFT ANGLE
• 10705034219929: CONCORDE SYSTEM RASP, STRAIGHT BAYONETED
• 10705034219912: CONCORDE SYSTEM RASP, STRAIGHT
• 10705034217253: CONCORDE LS LATERAL CAGE SYSTEM RASP, STRAIGHT
• 10705034217246: CONCORDE LS LATERAL CAGE SYSTEM ANGLED RASP
• 10705034305721: CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 11 x 13 x 21/25mm, 0 DEGREES
• 10705034305684: CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 11 x 9 x 21/25mm, 0 DEGREES
• 10705034305592: CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 9 x 11 x 21/25mm, 0 DEGREES
• 10705034305578: CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 9 x 9 x 21/25mm, 0 DEGREES
• 10705034305554: CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 9 x 7 x 21/25mm, 0 DEGREES