Hyper-C Anterior Cervical Plate System 0201-4012V

GUDID 00842048106159

Bone Screw, Self Drilling, 4.0 X 12 Variable

DEGEN MEDICAL, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00842048106159
• NIH Device Record Key: e006c9e5-9f0e-410b-9714-d1a8d58750c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyper-C Anterior Cervical Plate System
• Version Model Number: 0201-4012V
• Catalog Number: 0201-4012V
• 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

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048106159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150759

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00842048106159]

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: 2016-08-31

On-Brand Devices [Hyper-C Anterior Cervical Plate System]

• 00842048107873: 5-Level Plate, Size 103
• 00842048107866: 5-Level Plate, Size 98
• 00842048107859: 5-Level Plate, Size 93
• 00842048107842: 5-Level Plate, Size 88
• 00842048107835: 5-Level Plate, Size 83
• 00842048107828: 5-Level Plate, Size 78
• 00842048107811: 5-Level Plate, Size 73
• 00842048107804: 5-Level Plate, Size 68
• 00842048107798: 4-Level Plate, Size 88
• 00842048107781: 4-Level Plate, Size 84
• 00842048107774: 4-Level Plate, Size 80
• 00842048107767: 4-Level Plate, Size 76
• 00842048107750: 4-Level Plate, Size 72
• 00842048107743: 4-Level Plate, Size 68
• 00842048107736: 4-Level Plate, Size 64
• 00842048107729: 4-Level Plate, Size 60
• 00842048107712: 4-Level Plate, Size 56
• 00842048107705: 4-Level Plate, Size 52
• 00842048107699: 3-Level Plate, Size 65
• 00842048107682: 3-Level Plate, Size 62
• 00842048107675: 3-Level Plate, Size 59
• 00842048107668: 3-Level Plate, Size 56
• 00842048107651: 3-Level Plate, Size 53
• 00842048107644: 3-Level Plate, Size 50
• 00842048107637: 3-Level Plate, Size 47
• 00842048107620: 3-Level Plate, Size 44
• 00842048107613: 3-Level Plate, Size 41
• 00842048107606: 3-Level Plate, Size 38
• 00842048107590: 3-Level Plate, Size 35
• 00842048107583: 2-Level Plate, Size 44
• 00842048107576: 2-Level Plate, Size 42
• 00842048107569: 2-Level Plate, Size 40
• 00842048107552: 2-Level Plate, Size 38
• 00842048107545: 2-Level Plate, Size 36
• 00842048107538: 2-Level Plate, Size 34
• 00842048107521: 2-Level Plate, Size 32
• 00842048107514: 2-Level Plate, Size 30
• 00842048107507: 2-Level Plate, Size 28
• 00842048107491: 2-Level Plate, Size 26
• 00842048107484: 2-Level Plate, Size 25
• 00842048107477: 2-Level Plate, Size 24
• 00842048107460: 2-Level Plate, Size 23
• 00842048107453: 2-Level Plate, Size 22
• 00842048107446: 1-Level Plate, Size 27
• 00842048107439: 1-Level Plate, Size 25
• 00842048107422: 1-Level Plate, Size 23
• 00842048107415: 1-Level Plate, Size 21
• 00842048107408: 1-Level Plate, Size 19
• 00842048107392: 1-Level Plate, Size 17
• 00842048107385: 1-Level Plate, Size 15