BIOARCH
GUDID 00840420128928
WRIGHT MEDICAL TECHNOLOGY, INC.
Subtalar implant, non-bioabsorbable, sterile| Primary Device ID | 00840420128928 |
| NIH Device Record Key | 1f48bf84-2d1d-4c97-b35f-eeda738d12f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOARCH |
| Version Model Number | ST1112 |
| Company DUNS | 807201207 |
| Company Name | WRIGHT MEDICAL TECHNOLOGY, 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 | true |
| Expiration Date | false |
| 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 | |
| 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
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420128928 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070441
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
[00840420128928]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-01 |
On-Brand Devices [BIOARCH]
| 00889797053242 | ST1030 |
| 00840420128928 | ST1112 |
| 00840420128911 | ST1111 |
| 00840420128904 | ST1110 |
| 00840420128898 | ST1109 |
| 00840420128881 | ST1108 |
| 00889797053228 | Insertion Driver Subtalar System |
| 00889797055482 | Subtalar Implant Alignment Rod |
| 00889797055475 | Alignment Rod |
| 00889797053235 | Probe Subtalar System |
| 00889797053297 | Trial Sizer |
| 00889797053280 | Trial Sizer |
| 00889797053273 | Trial Sizer |
| 00889797053266 | Trial Sizer |
| 00889797053259 | Trial Sizer |
Trademark Results [BIOARCH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOARCH 77210412 3474925 Live/Registered |
Koby Ventures, L.P. 2007-06-20 |
 BIOARCH 74456420 1854561 Dead/Cancelled |
J2B2, Inc. 1993-11-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.