Navigation 161-0007
GUDID M7401610007
Drill, 4.5
SPINEOLOGY INC.
Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | M7401610007 |
| NIH Device Record Key | 6094450f-c0b6-4656-b8a2-7c12a3962b7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navigation |
| Version Model Number | 16-05-01-2 |
| Catalog Number | 161-0007 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
Customer Support Contacts
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com |
Device Dimensions
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 4.5 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7401610007 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180796
FDA Product Code
| OLO | Orthopedic stereotaxic instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
[M7401610007]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-07-22 |
| Device Publish Date | 2018-08-28 |
On-Brand Devices [Navigation]
| M7401610015 | Awl Stylet |
| M7401610026 | Screwdriver, Fortress |
| M7401610025 | Screwdriver, Palisade |
| M7401610023 | Solid Tap, 7.5 |
| M7401610022 | Solid Tap, 6.5 |
| M7401610021 | Solid Tap, 5.5 |
| M7401610020 | Solid Tap, 4.5 |
| M7401610017 | Cannulated Navigation Awl |
| M7401610012 | Screwdriver, Threshold |
| M7401610010 | Navigation Awl |
| M7401610009 | Drill, 6.5 |
| M7401610008 | Drill, 5.5 |
| M7401610007 | Drill, 4.5 |
| M7401610006 | Drill, 3.5 |
| M7401610005 | Cannulated Tap, 7.5 |
| M7401610004 | Cannulated Tap, 6.5 |
| M7401610003 | Cannulated Tap, 5.5 |
| M7401610002 | Cannulated Tap, 4.5 |
Trademark Results [Navigation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVIGATION 97187682 not registered Live/Pending |
NVGTN, LLC 2021-12-23 |
 NAVIGATION 88148112 not registered Dead/Abandoned |
Graton Spirits Company 2018-10-09 |
 NAVIGATION 85577656 not registered Dead/Abandoned |
RBZ Vineyards, LLC 2012-03-22 |
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