ORTHOSPHERE
GUDID 00840420199256
WRIGHT MEDICAL TECHNOLOGY, INC.
Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable| Primary Device ID | 00840420199256 |
| NIH Device Record Key | 948ee099-7ce0-48d4-b83e-5d6c9b7de8ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOSPHERE |
| Version Model Number | 8531011 |
| 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 | false |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420199256 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030319
FDA Product Code
| HWT | Template |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
[00840420199256]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-28 |
On-Brand Devices [ORTHOSPHERE]
| 00840420121813 | 8530014 |
| 00840420121806 | 8530013 |
| 00840420121790 | 8530012 |
| 00840420121783 | 8530011 |
| 00840420121776 | 8530010 |
| 00840420121769 | 8530009 |
| 00840420199485 | 8534114 |
| 00840420199478 | 8534113 |
| 00840420199461 | 8534112 |
| 00840420199454 | 8534111 |
| 00840420199447 | 8534110 |
| 00840420199430 | 8534109 |
| 00840420199423 | 8534012 |
| 00840420199416 | 8534011 |
| 00840420199393 | 8534004 |
| 00840420199386 | 8534003 |
| 00840420199324 | 8531020 |
| 00840420199317 | 8531019 |
| 00840420199263 | 8531012 |
| 00840420199256 | 8531011 |
| 00840420199232 | 8531009 |
Trademark Results [ORTHOSPHERE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOSPHERE 75398262 2293418 Live/Registered |
Wright Medical Technology, Inc. 1997-12-01 |
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