| Primary Device ID | 07630542769023 |
| NIH Device Record Key | 866253f8-de16-4d29-a41b-125b2e6d7d0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MSS - Monobloc stem |
| Version Model Number | 04.01.10.0981 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630542769023 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630542769023]
Moist Heat or Steam Sterilization
[07630542769023]
Moist Heat or Steam Sterilization
[07630542769023]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-13 |
| Device Publish Date | 2026-02-05 |
| 07630971255241 | Impactor tip for double eccenter |
| 07630542770920 | Humeral IM Cutting Guide 140° - Uncaptured |
| 07630542770913 | Monobloc stem Spacer Impactor Tip |
| 07630542769207 | Depth gauge for distal screw |
| 07630542769191 | Drill bit for distal screw |
| 07630542769184 | Drill guide for distal screw |
| 07630542769177 | Sleeve for distal screw |
| 07630542769160 | EM guide for distal screws |
| 07630542769153 | Monobloc Stem Inserter |
| 07630542769146 | Trial Monobloc Stem Double Eccenter – LARGE |
| 07630542769139 | Trial Monobloc Stem Double Eccenter – SMALL |
| 07630542769122 | Trial Monobloc Stem Spacer – LARGE |
| 07630542769115 | Trial Monobloc Stem Spacer – SMALL |
| 07630542769108 | Trial Monobloc Stem Metaphysis - 4 |
| 07630542769092 | Trial Monobloc Stem Metaphysis - 3 |
| 07630542769085 | Trial Monobloc Stem Metaphysis - 2 |
| 07630542769078 | Trial Monobloc Stem Metaphysis - 1 |
| 07630542769061 | Monobloc Stem Reamer - 4 |
| 07630542769054 | Monobloc Stem Reamer - 3 |
| 07630542769047 | Monobloc Stem Reamer - 2 |
| 07630542769030 | Monobloc Stem Reamer - 1 |
| 07630542769023 | Monobloc Stem Humeral Reaming Guide |
| 07630542769016 | Monobloc Stem Humeral Broach Handle |
| 07630542769009 | Short Monobloc Stem Broach – Ø16 |
| 07630542768996 | Short Monobloc Stem Broach – Ø15 |
| 07630542768989 | Short Monobloc Stem Broach – Ø14 |
| 07630542768972 | Short Monobloc Stem Broach – Ø13 |
| 07630542768965 | Short Monobloc Stem Broach – Ø12 |
| 07630542768958 | Short Monobloc Stem Broach – Ø11 |
| 07630542768941 | Short Monobloc Stem Broach – Ø10 |
| 07630542768934 | Short Monobloc Stem Broach – Ø9 |
| 07630542768927 | Short Monobloc Stem Broach – Ø8 |
| 07630542768910 | Short Monobloc Stem Broach – Ø7 |
| 07630542768903 | Short Monobloc Stem Broach – Ø6 |
| 07630542768897 | Standard Monobloc Stem Broach – Ø16 |
| 07630542768880 | Standard Monobloc Stem Broach – Ø15 |
| 07630542768873 | Standard Monobloc Stem Broach – Ø14 |
| 07630542768866 | Standard Monobloc Stem Broach – Ø13 |
| 07630542768859 | Standard Monobloc Stem Broach – Ø12 |
| 07630542768842 | Standard Monobloc Stem Broach – Ø11 |
| 07630542768835 | Standard Monobloc Stem Broach – Ø10 |
| 07630542768828 | Standard Monobloc Stem Broach – Ø9 |
| 07630542768811 | Standard Monobloc Stem Broach – Ø8 |
| 07630542768804 | Standard Monobloc Stem Broach – Ø7 |
| 07630542768798 | Standard Monobloc Stem Broach – Ø6 |
| 07630542768781 | Humeral IM Cutting Guide 140° - Captured |
| 07630542768774 | Humeral EM Cutting Guide 140° |
| 07630542768767 | Trial hum. rev. liner Ø42/+6 - LARGE |
| 07630542768750 | Trial hum. rev. liner Ø42/+3 - LARGE |
| 07630542768743 | Trial hum. rev. liner Ø42/+0 - LARGE |