MaxTorque™
GUDID 00846832054374
TORNIER, INC.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 00846832054374 |
| NIH Device Record Key | 3f7febee-797f-442c-926a-5711274f91d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MaxTorque™ |
| Version Model Number | SP-MSD-40-022F |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832054374 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060428
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
[00846832054374]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [MaxTorque™]
| 00846832058686 | SP-MSD-55-110F |
| 00846832058679 | SP-MSD-55-105F |
| 00846832058662 | SP-MSD-55-100F |
| 00846832058655 | SP-MSD-55-095F |
| 00846832058648 | SP-MSD-55-090F |
| 00846832058631 | SP-MSD-55-085F |
| 00846832058624 | SP-MSD-55-080F |
| 00846832058617 | SP-MSD-55-075F |
| 00846832058600 | SP-MSD-40-070F |
| 00846832058594 | SP-MSD-40-065F |
| 00846832058587 | SP-MSD-40-060F |
| 00846832058570 | SP-MSD-40-055F |
| 00846832058563 | MSD-010-55-475P |
| 00846832058556 | MSD-010-55-110P |
| 00846832058549 | MSD-010-55-105P |
| 00846832058532 | MSD-010-55-100P |
| 00846832058525 | MSD-010-55-095P |
| 00846832058518 | MSD-010-55-090P |
| 00846832058501 | MSD-010-55-085P |
| 00846832058495 | MSD-010-55-080P |
| 00846832058488 | MSD-010-55-075P |
| 00846832058471 | MSD-010-55-070P |
| 00846832058464 | MSD-010-55-065P |
| 00846832058457 | MSD-010-55-060P |
| 00846832058440 | MSD-010-55-055P |
| 00846832058433 | MSD-010-55-050P |
| 00846832058426 | MSD-010-55-045P |
| 00846832058419 | MSD-010-55-040P |
| 00846832054879 | SP-MSD-70-475F |
| 00846832054862 | SP-MSD-70-425F |
| 00846832054855 | SP-MSD-70-375F |
| 00846832054848 | SP-MSD-70-130F |
| 00846832054831 | SP-MSD-70-125F |
| 00846832054824 | SP-MSD-70-120F |
| 00846832054817 | SP-MSD-70-115F |
| 00846832054800 | SP-MSD-70-110F |
| 00846832054794 | SP-MSD-70-105F |
| 00846832054787 | SP-MSD-70-100F |
| 00846832054770 | SP-MSD-70-095F |
| 00846832054763 | SP-MSD-70-090F |
| 00846832054756 | SP-MSD-70-085F |
| 00846832054749 | SP-MSD-70-080F |
| 00846832054732 | SP-MSD-70-075F |
| 00846832054725 | SP-MSD-70-070F |
| 00846832054718 | SP-MSD-70-065F |
| 00846832054701 | SP-MSD-70-060F |
| 00846832054695 | SP-MSD-70-055F |
| 00846832054688 | SP-MSD-70-050F |
| 00846832054671 | SP-MSD-70-045F |
| 00846832054664 | SP-MSD-70-040F |
Trademark Results [MaxTorque]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAXTORQUE 78876548 3337167 Live/Registered |
OrthoHelix Surgical Designs, Inc. 2006-05-04 |
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