| Primary Device ID | 00889024183315 |
| NIH Device Record Key | bfc38e97-27c8-4d39-9d95-70f2e281b5f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9510-22-400 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, 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 | false |
| 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 |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024183315 [Primary] |
| KXA | Prosthesis, hip, femoral, resurfacing |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
[00889024183315]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-07-20 |
| 00887868585661 - Zimmer Biomet® 12/14 Spherical Head Trials | 2024-11-19 |
| 00887868139628 - Affixus® | 2024-11-18 |
| 00887868139635 - Affixus® | 2024-11-18 |
| 00887868139642 - Affixus® | 2024-11-18 |
| 00887868139659 - Affixus® | 2024-11-18 |
| 00887868139666 - Affixus® | 2024-11-18 |
| 00887868139673 - Affixus® | 2024-11-18 |
| 00887868139680 - Affixus® | 2024-11-18 |