CAVUX™ Cervical Cage-L 8x12x15mm 7 deg PD-31-602

GUDID 10852776006277

CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 10852776006277
• NIH Device Record Key: 75f868f3-3dc4-465f-86c8-6e358d733df9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAVUX™ Cervical Cage-L 8x12x15mm 7 deg
• Version Model Number: PD-31-602
• Catalog Number: PD-31-602
• Company DUNS: 969820245
• Company Name: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852776006270 [Primary]
GS1	10852776006277 [Package]; Contains: 00852776006270; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-10-14

Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.

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• 10852776006277 - CAVUX™ Cervical Cage-L 8x12x15mm 7 deg: 2020-02-24CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
• 10852776006277 - CAVUX™ Cervical Cage-L 8x12x15mm 7 deg: 2020-02-24 CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical sp
• 10852776006321 - CAVUX™ Cervical Cage-B 5mm: 2020-02-24 CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spin