| Primary Device ID | 07630971265684 |
| NIH Device Record Key | f8d2fa12-f9fb-462f-9880-610627873cce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hip Instrument |
| Version Model Number | 01.26.10.0074 |
| 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 | 07630971265684 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
[07630971265684]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-28 |
| Device Publish Date | 2025-03-20 |
| 07630971254824 | Pincer impaction plate DMB |
| 07630971254817 | Pincer impaction plate DMA |
| 07630971266360 | Liner Impaction sphere assembly Ø40 |
| 07630971266353 | Liner Impaction sphere assembly Ø22 |
| 07630971266346 | Liner Impaction sphere assembly Ø36 |
| 07630971266339 | Liner Impaction sphere assembly Ø32 |
| 07630971266322 | Liner Impaction sphere assembly Ø28 |
| 07630345774941 | Trial Neck F V2 SN 6-7-8-9-10LAT |
| 07630345774934 | Trial Neck F V2 SN 4-5LAT |
| 07630345774927 | Trial Neck F V2 SN 2-3LAT |
| 07630345774910 | Trial Neck F V2 SN 0-1LAT |
| 07630345774903 | Trial Neck F V2 SN 8-9-10STD |
| 07630345774897 | Trial Neck F V2 SN 5-6-7STD |
| 07630345774880 | Trial Neck F V2 SN 2-3-4STD |
| 07630345774873 | Trial Neck F V2 SN 00-0-1STD |
| 07630345774866 | Trial Neck F V2 6-7-8-9-10LAT |
| 07630345774859 | Trial Neck F V2 4-5LAT |
| 07630345774842 | Trial Neck F V2 2-3LAT |
| 07630345774835 | Trial Neck F V2 0-1LAT |
| 07630345774828 | Trial Neck F V2 8-9-10STD |
| 07630345774811 | Trial Neck F V2 5-6-7STD |
| 07630345774804 | Trial Neck F V2 2-3-4STD |
| 07630345774798 | Trial Neck F V2 00-0-1STD |
| 07630542724268 | Calcar Reamer Head - #L - Diamond teeth |
| 07630542724251 | Calcar Reamer Head - #M - Diamond teeth |
| 07630542724244 | Calcar Reamer Head - #S - Diamond teeth |
| 07630542724213 | Female Flush Calcar Reamer ZH-Shaft |
| 07630542724176 | Male Flush Calcar Reamer ZH-Shaft |
| 07630971265691 | Trial shell Ø 38 |
| 07630971265684 | Trial double mobility liner 22.2/DMAZ |
| 07630345734433 | Versacem trials steril. tray |
| 07630040741156 | Trial cup Ø40 |
| 07630040754026 | Mpact Posterior alignment cup impactor |
| 07630040749473 | Anteversion rod |
| 07630040749466 | Inclination rod |