| Primary Device ID | 00840420198761 |
| NIH Device Record Key | 1d438c04-cf2a-4ca6-a9a9-300f595a7cd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 4940101 |
| 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 |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420198761 [Primary] |
| KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840420198761]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-17 |
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| 00889797113854 - Incompass Total Ankle System | 2025-08-22 Tibial Stem |
| 00889797113861 - Incompass Total Ankle System | 2025-08-22 Tibial Stem |
| 00889797114035 - Incompass Total Ankle System | 2025-08-22 Tibial Stem |