| Primary Device ID | 00850030203229 |
| NIH Device Record Key | 6ddabc06-653f-4627-9d4b-8c53e903ae28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SixFix Circular Fixation System |
| Version Model Number | 1 |
| Catalog Number | 76-11085 |
| Company DUNS | 117990191 |
| Company Name | Amdt Holdings, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850030203229 [Primary] |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
[00850030203229]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-23 |
| Device Publish Date | 2021-04-15 |
| 00850030203687 | 2/3 Ring, 195mm |
| 00850030203670 | 2/3 Ring, 175mm |
| 00850030203663 | 2/3 Ring, 155mm |
| 00850030203656 | 2/3 Ring, 135mm |
| 00850030203526 | Foot Arch, 180mm |
| 00850030203519 | Foot Arch, 150mm |
| 00850030203502 | Foot Rocker, Short |
| 00850030203496 | Foot Rocker, Long |
| 00850030203489 | Foot Ring, 180mm, Short |
| 00850030203472 | Foot Ring, 180mm, Long |
| 00850030203465 | Foot Ring, 150mm, Short |
| 00850030203458 | Foot Ring, 150mm, Long |
| 00850030203441 | Full Ring, 195mm |
| 00850030203434 | Full Ring, 175mm |
| 00850030203427 | Full Ring, 155mm |
| 00850030203410 | Full Ring, 135mm |
| 00850030203403 | Strut Clip, Plastic |
| 00850030203397 | SixFix Strut Assembly, 100mm - Base Unit |
| 00850030203380 | Strut Screw Add-on, 100mm |
| 00850030203120 | Motion Hinge |
| 00850030203113 | Foot Arch with Locking Hinge, 150mm |
| 00850030203106 | Foot Arch with Locking Hinge, 180mm |
| 00850030203090 | Butt Frame Connector, 180mm |
| 00850030203083 | Butt Frame Connector, 150mm |
| 00850030203076 | 2/3 Ring, 225mm |
| 00850030203045 | Strut Assembly, 50mm - Base with Add-ons |
| 00850030203038 | Strut Assembly, 100mm - Base with Add-ons |
| 00850030203021 | Reduction Strut, Medium |
| 00850030203014 | Reduction Strut, Short |
| 00850030203007 | Shoulder Screw |
| 00850030203564 | 4-Hole Threaded Posts |
| 00850030203557 | 2-Hole Threaded Posts |
| 00850030203540 | Half Pin Fixation Bolt |
| 00850030203533 | Wire Fixation Bolt, XL |
| 00850030203298 | Standard Hex Bolt 6 mm X 20 mm |
| 00850030203281 | Standard Hex Bolt 6 mm X 16 mm |
| 00850030203274 | Standard Hex Bolt 6 mm X 12 mm |
| 00850030203267 | Rancho Bolt, 6mm x 7mm |
| 00850030203199 | 30-Degree Pin Block |
| 00850030203182 | 15-Degree Pin Block |
| 00850030203175 | 6-Hole Threaded Posts |
| 00850030203168 | 5-Hole Threaded Posts |
| 00850030203151 | 3-Hole Threaded Posts |
| 00850030203144 | Variable Angle Clamp, Tall |
| 00850030203137 | Variable Angle Clamp, Short |
| 00850030203069 | SixFix Strut Assembly, 50mm - Base Unit |
| 00850030203052 | Strut Screw Add-on, 50mm |
| 00850030203649 | Static Strut, Extra Long (80mm) |
| 00850030203632 | Static Strut, Long (60mm) |
| 00850030203625 | Static Strut, Medium (40mm) |