ORTHOSPHERE
GUDID 00840420121776
WRIGHT MEDICAL TECHNOLOGY, INC.
Total wrist carpus prosthesis| Primary Device ID | 00840420121776 |
| NIH Device Record Key | 58c90665-64e5-4f40-b04a-5bd0ef7dfc80 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOSPHERE |
| Version Model Number | 8530010 |
| 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 | 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 | |
| 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 | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420121776 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030319
FDA Product Code
| KWD | PROSTHESIS, TOE, HEMI-, PHALANGEAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
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 [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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