Cohere

GUDID 00195377006769

COHERE Cervical, 8x14x12mm 7°

Nuvasive, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00195377006769
• NIH Device Record Key: 700d8846-ef6e-4b4f-8227-375c7e7c7c2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cohere
• Version Model Number: 4081427P2
• Company DUNS: 053950783
• Company Name: Nuvasive, 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: true
• Expiration Date: true
• 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(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195377006769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173030

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

[00195377006769]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-22
• Device Publish Date: 2021-06-14

On-Brand Devices [Cohere]

• 00887517982841: COHERE XL, 12x18x55mm 10°
• 00887517982827: COHERE XL, 12x18x50mm 10°
• 00887517982766: COHERE XL, 10x18x55mm 10°
• 00887517982742: COHERE XL, 10x18x50mm 10°
• 00887517982681: COHERE XL, 8x18x55mm 10°
• 00887517982667: COHERE XL, 8x18x50mm 10°
• 00887517983329: COHERE XLW, 12x22x55mm 10°
• 00887517983305: COHERE XLW, 12x22x50mm 10°
• 00887517983244: COHERE XLW, 10x22x55mm 10°
• 00887517983220: COHERE XLW, 10x22x50mm 10°
• 00887517983169: COHERE XLW, 8x22x55mm 10°
• 00887517983145: COHERE XLW, 8x22x50mm 10°
• 00887517982360: COHERE XLW, 12x22x55mm 15°
• 00887517982346: COHERE XLW, 12x22x50mm 15°
• 00887517982285: COHERE XLW, 10x22x55mm 15°
• 00887517982261: COHERE XLW, 10x22x50mm 15°
• 00887517982209: COHERE XLW, 8x22x55mm 15°
• 00887517982186: COHERE XLW, 8x22x50mm 15°
• 00887517943538: COHERE Tamp, Assembly HS
• 00887517025937: Alpha Cohere TLIF-O Core Instrument Set
• 00887517014047: COHERE TLIF-O Trial, 16x10mm 12°
• 00887517014023: COHERE TLIF-O Trial, 14x14mm 4°
• 00887517014016: COHERE TLIF-O Trial, 14x10mm 12°
• 00887517014009: COHERE TLIF-O Trial, 14x10mm 4°
• 00887517013255: COHERE TLIF-O Inserter, 14mm
• 00887517013248: COHERE TLIF-O Inserter, 10x30-35mm
• 00887517013231: COHERE TLIF-O Inserter, 10x25mm
• 00887517013187: COHERE TLIF-O Trial, 12x14mm 4°
• 00887517013170: COHERE TLIF-O Trial, 12x10mm 12°
• 00887517013163: COHERE TLIF-O Trial, 12x10mm 4°
• 00887517013156: COHERE TLIF-O Trial, 11x10mm 8°
• 00887517013149: COHERE TLIF-O Trial, 10x14mm 4°
• 00887517013125: COHERE TLIF-O Trial, 10x10mm 4°
• 00195377028150: COHERE TLIF-O Trial, 12x10mm 8°
• 00195377028143: COHERE TLIF-O Trial, 14x10mm 8°
• 00195377028136: COHERE TLIF-O Trial, 16x10mm 4°
• 00195377028129: COHERE TLIF-O Trial, 16x10mm 8°
• 00195377028112: COHERE TLIF-O Trial, 18x10mm 8°
• 00195377028105: COHERE TLIF-O Trial, 18x10mm 12°
• 00887517984067: COHERE XLXW, 8x26x60mm 0°
• 00887517984043: COHERE XLXW, 8x26x55mm 0°
• 00887517984029: COHERE XLXW, 8x26x50mm 0°
• 00887517984005: COHERE XLXW, 8x26x45mm 0°
• 00887517983985: COHERE XLXW, 12x26x60mm 0°
• 00887517983961: COHERE XLXW, 12x26x55mm 0°
• 00887517983947: COHERE XLXW, 12x26x50mm 0°
• 00887517983923: COHERE XLXW, 12x26x45mm 0°
• 00887517983909: COHERE XLXW, 10x26x60mm 0°
• 00887517983886: COHERE XLXW, 10x26x55mm 0°
• 00887517983862: COHERE XLXW, 10x26x50mm 0°