| Primary Device ID | 00840338604040 |
| NIH Device Record Key | d66b3b32-d50a-452b-bc63-82d2f0d68621 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tornier HRS Max |
| Version Model Number | ARS10253 |
| Catalog Number | ARS10253 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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 | 00840338604040 [Primary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
[00840338604040]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-26 |
| Device Publish Date | 2025-11-18 |
| 00840338612229 | Deep Image Aluminum Lid |
| 00840338607379 | Instrument Tray Assembly |
| 00840338604101 | Instrument Case Base |
| 00840338604095 | Instrument Inner Tray |
| 00840338604088 | Taper Breaker |
| 00840338604071 | Impactor Tip |
| 00840338604064 | Impaction Stand |
| 00840338604057 | Trial Alignment Peg |
| 00840338604040 | Trial Tuberosity Body |
| 00840338604033 | Trial Tuberosity Body |
| 00840338604026 | Trial Proximal Body |
| 00840338604019 | Trial Proximal Body |
| 00840338604002 | Trial Proximal Body |
| 00840338603999 | Trial Spacer |
| 00840338603982 | Trial Spacer |
| 00840338603975 | Trial Spacer |
| 00840338603968 | Trial Spacer |
| 00840338603951 | Height Gauge Tower |
| 00840338603944 | Height Gauge Clamp |
| 00840338603937 | Inserter & Extractor Handle |
| 00840338603920 | Expanding Trial |
| 00840338603913 | Expanding Trial |
| 00840338603906 | Expanding Trial |
| 00840338603890 | Expanding Trial |
| 00840338603883 | Expanding Trial |
| 00840338603876 | Expanding Trial |
| 00840338603869 | Expanding Trial |
| 00840338603852 | Expanding Trial |
| 00840338603845 | Expanding Trial |
| 00840338603838 | Expanding Trial |
| 00840338603821 | Expanding Trial |
| 00840338603708 | Drop Rod |
| 00840338603692 | Saw Guide |
| 00840338603685 | Bone Clamp |