| Primary Device ID | M7406704095 |
| NIH Device Record Key | e601795b-50cb-4468-b77c-724b974fd16b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Palisade Pedicular Fixation System |
| Version Model Number | 10-10-60-10 |
| Catalog Number | 670-4095 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 651-256-8500 |
| aadams@spineology.com |
| Outer Diameter | 4.75 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7406704095 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-06 |
| Device Publish Date | 2019-04-26 |
| M7406704095 | Palisade Fixed Curved Rod |
| M7406700071 | All In One Stylet, Short, Non-Sterile |
| M7406700070 | All In One Stylet, Long, Non-Sterile |
| M7406710074 | Revision Tower Reducer |
| M7406710068 | ASM, Locking Cap Ratchet Handle |
| M7409000007 | Ratcheting Axial Handle |
| M7409000005 | Torque Limiting Handle |
| M7406710075 | Counter Torque |
| M7406710073 | Alignment Tool |
| M7406710072 | Bone Rasp |
| M7406710071 | Rescue Tower |
| M7406710070 | Tower Adjustment Tool |
| M7406710061 | Rasp |
| M7406710060 | Impaction Cap |
| M7406710059 | Palisade Trajectory Portal |
| M7406710058 | Bevel Awl |
| M7406710057 | Trocar Awl |
| M7406710053 | Screw Height Adjuster |
| M7406710052 | Dilator One |
| M7406710051 | Rescue Sleeve |
| M7406710050 | Palm Handle Set Screw Placer |
| M7406710049 | Tulip Head Turner |
| M7406710048 | Rod Caliper |
| M7406710040 | Double Ended Set Screw Placer |
| M7406710036 | Tab Breaker |
| M7406710035 | Counter Torque |
| M7406710030 | Straight Rod Holder |
| M7406710027 | Compressor/Distractor Link |
| M7406710025 | Compressor/Distractor Tube |
| M7406710024 | Compressor/Distractor Handle |
| M7406710016 | Screwdriver |
| M7406710008 | Dilator Three |
| M7406710007 | Dilator Two |
| M7406710005 | Articulating Rod Holder Guide |
| M7406710004 | Ring Breaker |
| M7406710002 | Locking Set Screw Placer |
| M7406420001 | Rod Holder |
| M7405300045 | Rod Bender |
| M7405300042 | Ratcheting T-Handle |
| M7406710055 | Short 1/4 Drive Final Driver |
| M7406710015 | 7.5mm Tap |
| M7406710014 | 6.5mm Tap |
| M7406710013 | 5.5mm Tap |
| M7406710012 | 4.5mm Tap |
| M7401001284 | Stylet Wrench |