Lat-Fuse™ Lateral Plate System
GUDID 00846468014568
TORQUE LIMITING HANDLE
Pioneer Surgical Technology, Inc.
General internal orthopaedic fixation system implantation kit| Primary Device ID | 00846468014568 |
| NIH Device Record Key | bcec2019-91f2-47ca-8bfc-8ed89efee7a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lat-Fuse™ Lateral Plate System |
| Version Model Number | 38-TORQHANDLE |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, 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 |
Customer Support Contacts
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468014568 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120724
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
[00846468014568]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-05 |
On-Brand Devices [Lat-Fuse™ Lateral Plate System]
| 00846468078133 | PLATE CADDY |
| 00846468077778 | INSTRUMENT CASE |
| 00846468014568 | TORQUE LIMITING HANDLE |
| 00846468014551 | ARTICULATING PLATE HOLDER |
| 00846468014544 | SCREW SEAT INDICATOR |
| 00846468014537 | RATCHETING T-HANDLE |
| 00846468014520 | RATCHETING PALM STYLE HANDLE |
| 00846468014513 | SCREW TIGHTENER |
| 00846468014506 | TEMPORARY HOLDING PIN, LONG |
| 00846468014490 | TEMPORARY HOLDING PIN |
| 00846468014483 | SCREW INSERTER, SELF-RETAINED |
| 00846468014476 | SCREW INSERTER, THREADED |
| 00846468014469 | IN-LINE FIXED PLATE HOLDER |
| 00846468014452 | NUT LOCKER |
| 00846468014445 | MODULAR DRILL |
| 00846468014438 | CENTERING SLEEVE |
| 00846468014421 | MODULAR AWL |
Trademark Results [Lat-Fuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAT-FUSE 85605450 5022703 Live/Registered |
Pioneer Surgical Technology, Inc. 2012-04-23 |
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