| Primary Device ID | 28031497000521 |
| NIH Device Record Key | 3997551d-9723-41eb-84d9-56cc8b5628b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mendec Spine Kit |
| Version Model Number | 13C2000 |
| Company DUNS | 435428396 |
| Company Name | TECRES SPA |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 28031497000521 [Primary] |
| NDN | Cement, Bone, Vertebroplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2015-10-06 |
| 08031497003894 - InterSpace Hip Trial, 46mm Short | 2026-02-19 |
| 08031497003900 - InterSpace Hip Trial, 54mm Short | 2026-02-19 |
| 08031497003917 - InterSpace Hip Trial, 60mm Short | 2026-02-19 |
| 08031497003924 - InterSpace Hip Trial, 46mm Long | 2026-02-19 |
| 08031497003931 - InterSpace Hip Trial, 54mm Long | 2026-02-19 |
| 08031497003948 - InterSpace Hip Trial, 60mm Long | 2026-02-19 |
| 08031497003955 - Interspace GV Hip Spacer 46 | 2026-02-19 TAPERED WEDGE STEM |
| 08031497003962 - Interspace GV Hip Spacer 54 | 2026-02-19 TAPERED WEDGE STEM |