| Primary Device ID | 00841506105116 |
| NIH Device Record Key | 20942082-5708-4aa1-96fd-fe845e4d49a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IJS |
| Version Model Number | IJS-E Axis Pin 2.5mm x 55mm |
| Catalog Number | IJS-EAP-25550 |
| Company DUNS | 869056148 |
| Company Name | SKELETAL DYNAMICS L.L.C. |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com | |
| Phone | +1(305)596-7585 |
| feedback@skeletaldynamics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841506105116 [Primary] |
| LXT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE |
| OZI | Internal hinged elbow fixator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
[00841506105116]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-30 |
| 00841506105314 | Tissue Protector / Drill Guide, Single Sided, 2.0m |
| 00841506105307 | Dorsal Spanning Plate, Short, Ti |
| 00841506105291 | IJS Sterilization Tray, Instrument Tray (Branch) |
| 00841506105284 | IJS Sterilization Tray, Caddy (Branch) |
| 00841506105277 | IJS Sterilization Tray, Lid (Branch) |
| 00841506105260 | IJS Sterilization Tray, Base (Branch) |
| 00841506105253 | IJS-E Sterilization Tray |
| 00841506105246 | IJS-ELBOW, Counter Torque Tool |
| 00841506105239 | IJS-E Axis Centering Guide |
| 00841506105222 | Drill, Solid Side Cutting, 2.5mm x 80mm |
| 00841506105215 | Depth Gauge, Med. Standard, 50mm |
| 00841506105208 | IJS-E Drill, Cann Distal Cutting, 2.7mm x 70mm |
| 00841506105192 | IJS-E Depth Gauge, Over K-Wire |
| 00841506105185 | IJS-E Axis Guide, Lateral Approach, Sm |
| 00841506105178 | IJS-E Axis Guide, Lateral Approach, Md |
| 00841506105161 | IJS-E Axis Guide, Lateral Approach, Lg |
| 00841506105154 | IJS-E K-Wire Guide, 1.5mm |
| 00841506105147 | IJS-E Axis Pin 2.5mm x 70mm |
| 00841506105130 | IJS-E Axis Pin 2.5mm x 65mm |
| 00841506105123 | IJS-E Axis Pin 2.5mm x 60mm |
| 00841506105116 | IJS-E Axis Pin 2.5mm x 55mm |
| 00841506105109 | IJS-E Axis Pin 2.5mm x 50mm |
| 00841506105093 | IJS-E Axis Pin 2.5mm x 45mm |
| 00841506105086 | IJS-E Axis Pin 2.5mm x 40mm |
| 00841506105079 | IJS-E Axis Pin 2.5mm x 35mm |
| 00841506105062 | IJS-E Axis Pin 2.5mm x 30mm |
| 00841506105055 | Screw, Polyaxial Non Locking, 3.5mm x 44mm, Ti |
| 00841506105048 | Screw, Polyaxial Non Locking, 3.5mm x 42mm, Ti |
| 00841506105031 | Screw, Polyaxial Non Locking, 3.5mm x 40mm, Ti |
| 00841506105024 | Screw, Polyaxial Non Locking, 3.5mm x 38mm, Ti |
| 00841506105017 | Screw, Polyaxial Non Locking, 3.5mm x 36mm, Ti |
| 00841506105000 | Screw, Polyaxial Non Locking, 3.5mm x 34mm, Ti |
| 00841506104997 | Screw, Polyaxial Non Locking, 3.5mm x 32mm, Ti |
| 00841506104980 | Screw, Polyaxial Non Locking, 3.5mm x 30mm, Ti |
| 00841506104973 | Screw, Polyaxial Non Locking, 3.5mm x 28mm, Ti |
| 00841506104966 | Screw, Polyaxial Non Locking, 3.5mm x 26mm, Ti |
| 00841506104959 | Screw, Polyaxial Non Locking, 3.5mm x 24mm, Ti |
| 00841506104942 | Screw, Polyaxial Non Locking, 3.5mm x 22mm, Ti |
| 00841506104935 | Screw, Polyaxial Non Locking, 3.5mm x 20mm, Ti |
| 00841506104928 | Screw, Polyaxial Non Locking, 3.5mm x 18mm, Ti |
| 00841506104911 | Screw, Polyaxial Non Locking, 3.5mm x 16mm, Ti |
| 00841506104904 | IJS-E Base Plate Assembly |
| 00841506104898 | Packaged IJS-E System |
| 00841506132945 | IJS Axis Trajectory Guide, Rotated, Large, Left |
| 00841506132938 | IJS Axis Trajectory Guide, Rotated, Large, Right |
| 00841506132921 | IJS Axis Trajectory Guide, Rotated, Medium, Left |
| 00841506132914 | IJS Axis Trajectory Guide, Rotated, Medium, Right |
| 00841506132907 | IJS Axis Trajectory Guide, Rotated, Small, Left |
| 00841506132891 | IJS Axis Trajectory Guide, Rotated, Small, Right |
| 00841506132877 | Cutting Pliers |