| Primary Device ID | M716AH31400 |
| NIH Device Record Key | 3a832473-85e4-4bbd-86ef-440b25f1b658 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoMedFlex, LLC |
| Version Model Number | AH3-140 |
| Catalog Number | AH3-140 |
| Company DUNS | 034442726 |
| Company Name | ORTHOMEDFLEX LLC |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com | |
| Phone | 1-844-663-3539 |
| info@orthomedflex.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M716AH31400 [Primary] |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2017-04-25 |
| M7161121584600 | Trial Liner, 40/60-68E (+4 10° Hooded Lateralised) |
| M7161121584560 | Trial Liner, 40/56-58D (+4 10° Hooded Lateralised) |
| M7161121574600 | Trial Liner, 40/60-68E (+4 Neutral Lateralised) |
| M7161121574560 | Trial Liner, 40/56-58D (+4 Neutral Lateralised) |
| M7161111526440 | Ceramic Femoral Head, 40mm +8mm (XL) |
| M716AH15400 | Femoral Head, SIZE 40mm (XL) CoCr Alloy (+10mm) |
| M716AH14400 | Femoral Head, SIZE 40mm (XL) CoCr Alloy |
| M716AH13400 | Femoral Head SIZE 40mm, (L) CoCr Alloy |
| M716AH12400 | Femoral Head, SIZE 40mm (M) CoCr Alloy |
| M716AH11400 | Femoral Head, SIZE 40mm, (S) CoCr Alloy |
| M7161111912010 | Orion Stem, H/O (Lateralized), - Size 12 |
| M7161111912000 | Orion Stem, Standard Offset, Size 12 |
| M7161122800370 | Stepped Reamer |
| M7161013140 | Curved Reamer Assembly |
| M716101199S0 | Quick Connect Drill Bit, 35mm (Sterile) |
| M716101198S0 | Quick Connect Drill Bit (sterile) |
| M7161011350 | IM Drill Reamer |
| M7161011220 | Tapered Pin Reamer |
| M7161011200 | Stepped Entry Reamer |
| M716AH34400 | Ceramic Femoral Head, 40mm +8.0mm (XL) |
| M716AH33400 | Cermaic Femoral Head, 40mm +4.0mm (L) |
| M716AH32400 | Ceramic Femoral Head, 40mm +0.0mm (M) |
| M716AH31400 | Ceramic Femoral Head, 40mm -4.0mm (S) |
| M716101661020 | Non-Cemented Stem Magazine Insert - Orion |
| M716101661010 | Non-Cemented Stem Magazine Insert - Kratos |
| M7161016610 | Super Tray with Kratos & Orion Inserts |
| M7161016600 | Mudbox Tray used for transporting miscellaneous instruments. |
| M7161121525280 | Trial Liner, 40/60-68E (20 degree Hooded) |
| M7161121525270 | Trial Liner, 40/56-58D (20 degree Hooded) |
| M7161121521670 | Trial Liner, 40/60-68E (Neutral) |
| M7161121521660 | Trial Liner, 40/56-58D (Neutral) |
| M7161121521430 | Trial Liner, 40/60-68E (10 degree Hooded) |
| M7161121521420 | Trial Liner, 40/56-58D (10 degree Hooded) |
| M7161013450 | Femoral Rasp |