| Primary Device ID | 07613327019001 |
| NIH Device Record Key | 5a0a2001-e075-4fa2-8525-487e697bc621 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Restoration |
| Version Model Number | 6523-1117 |
| Catalog Number | 6523-1117 |
| Company DUNS | 058311945 |
| Company Name | Howmedica Osteonics Corp. |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327019001 [Primary] |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
| 07613327140927 | ADM Insert |
| 07613327140903 | ADM Insert |
| 07613327140897 | ADM Insert |
| 07613327140880 | ADM Insert |
| 07613327140873 | ADM Insert |
| 07613327140866 | ADM Insert |
| 07613327140842 | ADM Insert |
| 07613327140828 | ADM Insert |
| 07613327140804 | ADM Insert |
| 07613327140781 | ADM Insert |
| 07613327037173 | Plate Screw |
| 07613327037166 | Plate Screw |
| 07613327037159 | Plate Screw |
| 07613327037142 | Plate Screw |
| 07613327037135 | Plate Screw |
| 07613327037128 | Plate Screw |
| 07613327037111 | Plate Screw |
| 07613327037104 | Plate Screw |
| 07613327037098 | Plate Screw |
| 07613327037081 | Plate Screw |
| 07613327019872 | Acetabular Wedge Augment |
| 07613327019865 | Acetabular Wedge Augment |
| 07613327019858 | Acetabular Wedge Augment |
| 07613327019841 | Acetabular Wedge Augment |
| 07613327019834 | Acetabular Wedge Augment |
| 07613327019827 | Acetabular Wedge Augment |
| 07613327019810 | Acetabular Wedge Augment |
| 07613327019803 | Acetabular Wedge Augment |
| 07613327019797 | Acetabular Wedge Augment |
| 07613327019780 | Acetabular Wedge Augment |
| 07613327019773 | Acetabular Wedge Augment |
| 07613327019766 | Acetabular Wedge Augment |
| 07613327019759 | Acetabular Wedge Augment |
| 07613327019742 | Acetabular Wedge Augment |
| 07613327019735 | Acetabular Wedge Augment |
| 07613327019728 | Acetabular Wedge Augment |
| 07613327019711 | Acetabular Wedge Augment |
| 07613327019704 | Acetabular Wedge Augment |
| 07613327019551 | Hip Stem |
| 07613327019544 | Hip Stem |
| 07613327019537 | Hip Stem |
| 07613327019520 | Hip Stem |
| 07613327019513 | Hip Stem |
| 07613327019506 | Hip Stem |
| 07613327019490 | Hip Stem |
| 07613327019483 | Hip Stem |
| 07613327019476 | Hip Stem |
| 07613327019469 | Hip Stem |
| 07613327019452 | Hip Stem |
| 07613327019445 | Hip Stem |