Amendia

GUDID 00840916101749

SPINAL ELEMENTS

Bone-screw internal spinal fixation system

• Primary Device ID: 00840916101749
• NIH Device Record Key: 8651fe23-e895-4cb1-a569-61b0b1d1ac5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amendia
• Version Model Number: 10-01-6540-5
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840916101749 [Primary]

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[00840916101749]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-03
• Device Publish Date: 2014-09-24

On-Brand Devices [Amendia]

• 00840916103729: 10-01-4540-7
• 00840916103712: 10-01-4535-7
• 00840916103705: 10-01-4530-7
• 00840916102869: 10-01-6550-1
• 00840916102852: 10-01-6545-1
• 00840916102845: 10-01-6540-1
• 00840916102814: 10-01-5550-1
• 00840916102678: 10-01-7550-2
• 00840916102654: 10-01-7540-2
• 00840916102593: 10-01-6550-2
• 00840916102586: 10-01-6545-2
• 00840916102388: 10-06-6550-2
• 00840916102364: 10-06-6540-2
• 00840916102357: 10-06-6535-2
• 00840916102319: 10-06-5540-2
• 00840916102265: 10-03-7555-2
• 00840916102258: 10-03-7550-2
• 00840916102234: 10-03-7540-2
• 00840916102173: 10-03-6550-2
• 00840916102159: 10-03-6540-2
• 00840916101749: 10-01-6540-5
• 00840916101732: 10-01-6535-5
• 00840916101367: 10-07
• 00840916101183: 10707-090
• 00840916101145: 10707-070
• 00840916101107: 10707-050
• 00840916101084: 10707-040
• 00840916100995: 10706-120
• 00840916100933: 10706-090
• 00840916100926: 10706-085
• 00840916100865: 10706-055
• 00840916100858: 10706-050
• 00840916100735: 10705-150
• 00840916100087: 29-1-4550