DEXA-C CERVICAL INTERBODY SYSTEM

GUDID B5211163130750

Dexa-C 7° Dual Trial 5-6mm, MED

AURORA SPINE, INC.

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: B5211163130750
• NIH Device Record Key: 96388e87-8c99-4d9f-a3a5-bd1a281eea65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXA-C CERVICAL INTERBODY SYSTEM
• Version Model Number: 116-313-075
• Company DUNS: 079119091
• Company Name: AURORA 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us
• Phone: 760.424.2004
• Email: info@auroraspine.us

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5211163130750 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

[B5211163130750]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [DEXA-C CERVICAL INTERBODY SYSTEM]

• B5219500010: Implant Tote, Dexa-C
• B5219030010: Thermoformed Tray Dexa Outer
• B5219030000: Thermoformed Tray Dexa Inner
• B52111670130: Dexa-C Implant Overbox, Red
• B52111670120: Dexa-C Implant Overbox, Yellow
• B52111670110: Dexa-C Implant Overbox, Green
• B5211167000: Dexa-C Implant Box
• B5211166020: Dexa-C Caddy
• B5211166010: Dexa-C Instrument Tray HALF SIZE TRAY
• B5211166000: DEXA-C Instrument Tray FULL SIZE TRAY
• B52111631720: Dexa-C Inserter No Stop
• B52111631710: Dexa-C Inserter
• B52111631420: Dexa-C Rasp 12° SML 12x14 & MED 14x16
• B52111631410: Dexa-C Rasp 7° SML 12x14 & MED 14x16
• B5211163131280: Dexa-C 12° Dual Trial 11-12mm, MED
• B5211163131270: Dexa-C 12° Dual Trial 9-10mm, MED
• B5211163131260: Dexa-C 12° Dual Trial 7-8mm, MED
• B5211163131250: Dexa-C 12° Dual Trial 5-6mm, MED
• B5211163131240: Dexa-C 12° Dual Trial 11-12mm, SML
• B5211163131230: Dexa-C 12° Dual Trial 9-10mm, SML
• B5211163131220: Dexa-C 12° Dual Trial 7-8mm, SML
• B5211163131210: Dexa-C 12° Dual Trial 5-6mm, SML
• B5211163130780: Dexa-C 7° Dual Trial 11-12mm, MED
• B5211163130770: Dexa-C 7° Dual Trial 9-10mm, MED
• B5211163130760: Dexa-C 7° Dual Trial 7-8mm, MED
• B5211163130750: Dexa-C 7° Dual Trial 5-6mm, MED
• B5211163130740: Dexa-C 7° Dual Trial 11-12mm, SML
• B5211163130730: Dexa-C 7° Dual Trial 9-10mm, SML
• B5211163130720: Dexa-C 7° Dual Trial 7-8mm, SML
• B5211163130710: Dexa-C 7° Dual Trial 5-6mm, SML
• B5211161416709MD0: Mid Density 14mm x 16mm x 7° x 9mm
• B5211161416709LD0: Low Density 14mm x 16mm x 7° x 9mm
• B5211161416709HD0: High Density 14mm x 16mm x 7° x 9mm
• B5211161416708MD0: Mid Density 14mm x 16mm x 7° x 8mm
• B5211161416708LD0: Low Density 14mm x 16mm x 7° x 8mm
• B5211161416708HD0: High Density 14mm x 16mm x 7° x 8mm
• B5211161416707MD0: Mid Density 14mm x 16mm x 7° x 7mm
• B5211161416707LD0: Low Density 14mm x 16mm x 7° x 7mm
• B5211161416707HD0: High Density 14mm x 16mm x 7° x 7mm
• B5211161416706MD0: Mid Density 14mm x 16mm x 7° x 6mm
• B5211161416706LD0: Low Density 14mm x 16mm x 7° x 6mm
• B5211161416706HD0: High Density 14mm x 16mm x 7° x 6mm
• B5211161416705MD0: Mid Density 14mm x 16mm x 7° x 5mm
• B5211161416705LD0: Low Density 14mm x 16mm x 7° x 5mm
• B5211161416705HD0: High Density 14mm x 16mm x 7° x 5mm
• B5211161214709MD0: Mid Density 12mm x 14mm x 7° x 9mm
• B5211161214709LD0: Low Density 12mm x 14mm x 7° x 9mm
• B5211161214709HD0: High Density 12mm x 14mm x 7° x 9mm
• B5211161214708MD0: Mid Density 12mm x 14mm x 7° x 8mm
• B5211161214708LD0: Low Density 12mm x 14mm x 7° x 8mm