Kinos Axiom 3801.2510
GUDID 00850022178641
KINOS MEDICAL INC
Ankle prosthesis bearing| Primary Device ID | 00850022178641 |
| NIH Device Record Key | e755950e-a438-4e18-aeb0-d5656945239e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kinos Axiom |
| Version Model Number | 3801.2510 |
| Catalog Number | 3801.2510 |
| 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 | 00850022178641 [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]
Trademark Results [Kinos Axiom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KINOS AXIOM 90085435 not registered Live/Pending |
Kinos Medical Inc. 2020-07-31 |
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