INBONE
GUDID 00840420123855
WRIGHT MEDICAL TECHNOLOGY, INC.
Fixed-bearing total ankle prosthesis| Primary Device ID | 00840420123855 |
| NIH Device Record Key | 72fe4068-2780-4c09-a67a-50679df21a6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INBONE |
| Version Model Number | 200010901 |
| Company DUNS | 807201207 |
| Company Name | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com |
Device Dimensions
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420123855 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051023
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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-27 |
| Device Publish Date | 2015-10-01 |
On-Brand Devices [INBONE]
Trademark Results [INBONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INBONE 77501645 3835666 Live/Registered |
Wright Medical Technology, Inc. 2008-06-18 |
 INBONE 77112513 not registered Dead/Abandoned |
INBONE Technologies, Inc. 2007-02-21 |
 INBONE 77112393 not registered Dead/Abandoned |
INBONE Technologies, Inc. 2007-02-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.