Zavation
GUDID 00842166194403
Modular Screw 6.5 x 90
ZAVATION LLC
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00842166194403 |
| NIH Device Record Key | 58c53e79-3f0a-416a-9036-a9496b00ad96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zavation |
| Version Model Number | 383-6590-C |
| Company DUNS | 069472800 |
| Company Name | ZAVATION LLC |
| 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 |
Customer Support Contacts
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com | |
| Phone | 601-919-1119 |
| info@zavation.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842166194403 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222614
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
[00842166194403]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-26 |
| Device Publish Date | 2023-12-18 |
On-Brand Devices [Zavation]
| 00084216611481 | TLIF 30, 6deg -15 |
| 00842166176768 | MIS Caliper |
| 00842166176607 | MIS Compressor/Distractor |
| 00842166176591 | 25mm Dilator |
| 00842166176584 | 22mm Dilator |
| 00842166176577 | 19mm Dilator |
| 00842166176560 | 16mm Dilator |
| 00842166176553 | 13mm Dilator |
| 00842166176546 | 10mm Dilator |
| 00842166176508 | K-Wire, Blunt, Smooth |
| 00842166176225 | Parellel Distractor for 6.0mm |
| 00842166176218 | Parallel Compressor |
| 00842166176119 | Caliper |
| 00842166176058 | Large-T Torque Limiting Handle |
| 00842166175167 | Custom Distractor |
| 00842166118324 | Rod Cutter, 3.5mm |
| 00842166118317 | Torque Limiting Axial Handle, 25 in-lbs |
| 00842166118294 | Straight Handle, Spinner top |
| 00842166118270 | Rod Persuader, 3.5mm |
| 00842166118263 | Hook, Offset, Crosslink Inserter, scissor type |
| 00842166118249 | Rod Rocker |
| 00842166118225 | Hook Trial, 6.0mm |
| 00842166118218 | Hook Trial, 4.5mm |
| 00842166118195 | Torque Shaft, T-15 |
| 00842166118188 | Set Screw Inserter, T-15 |
| 00842166118171 | Polyaxial Screwdriver, 2.5mm straight hex - large handle |
| 00842166118164 | Polyaxial Screwdriver, 2.5mm straight hex - small handle |
| 00842166118140 | Tap 4.0mm |
| 00842166118133 | Tap 3.5mm |
| 00842166118126 | Tap 3.0mm |
| 00842166118119 | Screw Head Positioner |
| 00842166118041 | Drill Guide - 10-52mm height range |
| 00842166118034 | Awl - 2.0mm (0.078") diameter, 6mm tip length |
| 00842166118027 | Polyaxial Shaft Screw 4.0x50mm |
| 00842166118010 | Polyaxial Shaft Screw 4.0x48mm |
| 00842166118003 | Polyaxial Shaft Screw 4.0x46mm |
| 00842166117990 | Polyaxial Shaft Screw 4.0x44mm |
| 00842166117983 | Polyaxial Shaft Screw 4.0x42mm |
| 00842166117976 | Polyaxial Shaft Screw 4.0x40mm |
| 00842166117969 | Polyaxial Shaft Screw 4.0x38mm |
| 00842166117952 | Polyaxial Shaft Screw 4.0x36mm |
| 00842166117945 | Polyaxial Shaft Screw 4.0x34mm |
| 00842166117938 | Polyaxial Shaft Screw 4.0x32mm |
| 00842166117921 | Polyaxial Shaft Screw 4.0x30mm |
| 00842166117914 | Polyaxial Shaft Screw 4.0x28mm |
| 00842166117907 | Polyaxial Shaft Screw 4.0x26mm |
| 00842166117891 | Polyaxial Shaft Screw 4.0x24mm |
| 00842166117884 | Polyaxial Shaft Screw 4.0x22mm |
| 00842166117877 | Polyaxial Shaft Screw 4.0x20mm |
| 00842166117860 | 3.5mm x 50mm Polyaxial Shaft Screw |
Trademark Results [Zavation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZAVATION 85217926 not registered Dead/Abandoned |
Zavation, Inc. 2011-01-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.