QUANTUM
GUDID 03701337601492
IN2BONES
Fixed-bearing total ankle prosthesis| Primary Device ID | 03701337601492 |
| NIH Device Record Key | ab9254af-8d8b-4178-8f0c-dad7b26e95a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTUM |
| Version Model Number | M50 ST221 |
| Company DUNS | 263616749 |
| Company Name | IN2BONES |
| 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 Dimensions
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
| Length | 34.58 Millimeter |
| Length | 28 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701337601492 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191380
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 | 2020-07-06 |
| Device Publish Date | 2020-06-26 |
On-Brand Devices [QUANTUM]
Trademark Results [QUANTUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM 98867628 not registered Live/Pending |
Xplorian LLC 2024-11-22 |
 QUANTUM 98807712 not registered Live/Pending |
Into-Me-Sea LLC 2024-10-17 |
 QUANTUM 98804816 not registered Live/Pending |
QuantumADR LLC 2024-10-16 |
 QUANTUM 98719255 not registered Live/Pending |
Evolve Biologix Inc. 2024-08-27 |
 QUANTUM 98705080 not registered Live/Pending |
Intervet Inc. 2024-08-19 |
 QUANTUM 98650676 not registered Live/Pending |
Raynor Marketing Ltd. 2024-07-16 |
 QUANTUM 98424129 not registered Live/Pending |
HOUSE X AMERICA LLC 2024-02-27 |
 QUANTUM 98417725 not registered Live/Pending |
Meta Materials Inc. 2024-02-23 |
 QUANTUM 98388177 not registered Live/Pending |
Thomas P. Dakich 2024-02-02 |
 QUANTUM 98386723 not registered Live/Pending |
Kuku, Jalil 2024-02-01 |
 QUANTUM 98384415 not registered Live/Pending |
Starkey Laboratories, Inc. 2024-01-31 |
 QUANTUM 98362353 not registered Live/Pending |
The Upper Deck Company 2024-01-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.