Latitude-C Cervical Interbody Spacer System 0304-0916P

GUDID 00842048111078

Ti Cervical Spacer, Parallel, 9 X 16 X 14

DEGEN MEDICAL, INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00842048111078
• NIH Device Record Key: 1278f0ce-d977-433d-aead-6e504356a161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Latitude-C Cervical Interbody Spacer System
• Version Model Number: 0304-0916P
• Catalog Number: 0304-0916P
• Company DUNS: 078812602
• Company Name: DEGEN MEDICAL, 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: true
• 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(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com

Device Dimensions

• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Width: 16 Millimeter
• Depth: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048111078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151496

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

Moist Heat or Steam Sterilization

[00842048111078]

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: 2016-09-05

On-Brand Devices [Latitude-C Cervical Interbody Spacer System]

• 00842048116271: HA PEEK Cervical Spacer, Parallel, 14 X 20 X 15
• 00842048116264: HA PEEK Cervical Spacer, Parallel, 13 X 20 X 15
• 00842048116257: HA PEEK Cervical Spacer, Parallel, 12 X 20 X 15
• 00842048116240: HA PEEK Cervical Spacer, Parallel, 11 X 20 X 15
• 00842048116233: HA PEEK Cervical Spacer, Parallel, 10 X 20 X 15
• 00842048116226: HA PEEK Cervical Spacer, Parallel, 9 X 20 X 15
• 00842048116219: HA PEEK Cervical Spacer, Parallel, 8 X 20 X 15
• 00842048116202: HA PEEK Cervical Spacer, Parallel, 7 X 20 X 15
• 00842048116196: HA PEEK Cervical Spacer, Parallel, 6 X 20 X 15
• 00842048116189: HA PEEK Cervical Spacer, Parallel, 5 X 20 X 15
• 00842048116172: HA PEEK Cervical Spacer, Parallel, 14 X 18 X 14
• 00842048116165: HA PEEK Cervical Spacer, Parallel, 13 X 18 X 14
• 00842048116158: HA PEEK Cervical Spacer, Parallel, 12 X 18 X 14
• 00842048116141: HA PEEK Cervical Spacer, Parallel, 11 X 18 X 14
• 00842048116134: HA PEEK Cervical Spacer, Parallel, 10 X 18 X 14
• 00842048116127: HA PEEK Cervical Spacer, Parallel, 9 X 18 X 14
• 00842048116110: HA PEEK Cervical Spacer, Parallel, 8 X 18 X 14
• 00842048116103: HA PEEK Cervical Spacer, Parallel, 7 X 18 X 14
• 00842048116097: HA PEEK Cervical Spacer, Parallel, 6 X 18 X 14
• 00842048116080: HA PEEK Cervical Spacer, Parallel, 5 X 18 X 14
• 00842048116073: HA PEEK Cervical Spacer, Parallel, 14 X 16 X 14
• 00842048116066: HA PEEK Cervical Spacer, Parallel, 13 X 16 X 14
• 00842048116059: HA PEEK Cervical Spacer, Parallel, 12 X 16 X 14
• 00842048116042: HA PEEK Cervical Spacer, Parallel, 11 X 16 X 14
• 00842048116035: HA PEEK Cervical Spacer, Parallel, 10 X 16 X 14
• 00842048116028: HA PEEK Cervical Spacer, Parallel, 9 X 16 X 14
• 00842048116011: HA PEEK Cervical Spacer, Parallel, 8 X 16 X 14
• 00842048116004: HA PEEK Cervical Spacer, Parallel, 7 X 16 X 14
• 00842048115991: HA PEEK Cervical Spacer, Parallel, 6 X 16 X 14
• 00842048115984: HA PEEK Cervical Spacer, Parallel, 5 X 16 X 14
• 00842048115977: HA PEEK Cervical Spacer, Parallel, 14 X 14 X 12
• 00842048115960: HA PEEK Cervical Spacer, Parallel, 13 X 14 X 12
• 00842048115953: HA PEEK Cervical Spacer, Parallel, 12 X 14 X 12
• 00842048115946: HA PEEK Cervical Spacer, Parallel, 11 X 14 X 12
• 00842048115939: HA PEEK Cervical Spacer, Parallel, 10 X 14 X 12
• 00842048115922: HA PEEK Cervical Spacer, Parallel, 9 X 14 X 12
• 00842048115915: HA PEEK Cervical Spacer, Parallel, 8 X 14 X 12
• 00842048115908: HA PEEK Cervical Spacer, Parallel, 7 X 14 X 12
• 00842048115892: HA PEEK Cervical Spacer, Parallel, 6 X 14 X 12
• 00842048115885: HA PEEK Cervical Spacer, Parallel, 5 X 14 X 12
• 00842048115878: HA PEEK Cervical Spacer, Parallel, 14 X 12 X 12
• 00842048115861: HA PEEK Cervical Spacer, Parallel, 13 X 12 X 12
• 00842048115854: HA PEEK Cervical Spacer, Parallel, 12 X 12 X 12
• 00842048115847: HA PEEK Cervical Spacer, Parallel, 11 X 12 X 12
• 00842048115830: HA PEEK Cervical Spacer, Parallel, 10 X 12 X 12
• 00842048115823: HA PEEK Cervical Spacer, Parallel, 9 X 12 X 12
• 00842048115816: HA PEEK Cervical Spacer, Parallel, 8 X 12 X 12
• 00842048115809: HA PEEK Cervical Spacer, Parallel, 7 X 12 X 12
• 00842048115793: HA PEEK Cervical Spacer, Parallel, 6 X 12 X 12
• 00842048115786: HA PEEK Cervical Spacer, Parallel, 5 X 12 X 12