Kinos Axiom 3801.2210

GUDID 00850022178405

KINOS MEDICAL INC

Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing

• Primary Device ID: 00850022178405
• NIH Device Record Key: 5b9051f7-df0a-4c73-a4a8-9339a61e3fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Axiom
• Version Model Number: 3801.2210
• Catalog Number: 3801.2210
• Company DUNS: 081112239
• Company Name: KINOS 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: 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	00850022178405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192778

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-20
• Device Publish Date: 2020-10-12

On-Brand Devices [Kinos Axiom]

• 00850022178818: 5801.4103
• 00850022178801: 5801.4109
• 00850022178757: 5801.0011
• 00850022178740: 5801.0010
• 00850022178733: 5801.0009
• 00850022178726: 5801.0008
• 00850022178719: 5801.0007
• 00850022178702: 5801.0006
• 00850022178696: 5801.0005
• 00850022178689: 5801.0003
• 00850022178672: 5801.0002
• 00850022178665: 5801.0001
• 00850022178658: 3801.2512
• 00850022178641: 3801.2510
• 00850022178634: 3801.2508
• 00850022178627: 3801.2506
• 00850022178610: 3801.1512
• 00850022178603: 3801.1510
• 00850022178597: 3801.1508
• 00850022178580: 3801.1506
• 00850022178573: 3801.2412
• 00850022178566: 3801.2410
• 00850022178559: 3801.2408
• 00850022178542: 3801.2406
• 00850022178535: 3801.1412
• 00850022178528: 3801.1410
• 00850022178511: 3801.1408
• 00850022178504: 3801.1406
• 00850022178498: 3801.2312
• 00850022178481: 3801.2310
• 00850022178474: 3801.2308
• 00850022178467: 3801.2306
• 00850022178450: 3801.1312
• 00850022178443: 3801.1310
• 00850022178436: 3801.1308
• 00850022178429: 3801.1306
• 00850022178412: 3801.2212
• 00850022178405: 3801.2210
• 00850022178399: 3801.2208
• 00850022178382: 3801.2206
• 00850022178375: 3801.1212
• 00850022178368: 3801.1210
• 00850022178351: 3801.1208
• 00850022178344: 3801.1206
• 00850022178337: 3801.2112
• 00850022178320: 3801.2110
• 00850022178313: 3801.2108
• 00850022178306: 3801.2106
• 00850022178290: 3801.1112
• 00850022178283: 3801.1110