LAT-FUSE™* LATERAL PLATE SYSTEM 38-SD55-34
GUDID 00846468013486
SELF-DRILLING SCREW
Pioneer Surgical Technology, Inc.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00846468013486 |
| NIH Device Record Key | 309f67f4-34cf-436d-9593-15161660432c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LAT-FUSE™* LATERAL PLATE SYSTEM |
| Version Model Number | 38-SD55-34 |
| Catalog Number | 38-SD55-34 |
| 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 | 00846468013486 [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 |
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
Moist Heat or Steam Sterilization
[00846468013486]
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 | 2016-01-13 |
On-Brand Devices [LAT-FUSE™* LATERAL PLATE SYSTEM]
| 00846468049249 | LATERAL PLATE |
| 00846468049232 | LATERAL PLATE |
| 00846468014414 | LATERAL PLATE |
| 00846468014407 | LATERAL PLATE |
| 00846468014391 | LATERAL PLATE |
| 00846468014384 | LATERAL PLATE |
| 00846468014377 | LATERAL PLATE |
| 00846468014360 | LATERAL PLATE |
| 00846468014353 | LATERAL PLATE |
| 00846468014346 | LATERAL PLATE |
| 00846468014339 | LATERAL PLATE |
| 00846468014322 | LATERAL PLATE |
| 00846468014315 | LATERAL PLATE |
| 00846468014308 | SELF-DRILLING SCREW |
| 00846468014292 | SELF-DRILLING SCREW |
| 00846468014285 | SELF-DRILLING SCREW |
| 00846468014278 | SELF-DRILLING SCREW |
| 00846468014261 | SELF-DRILLING SCREW |
| 00846468014254 | SELF-DRILLING SCREW |
| 00846468014247 | SELF-DRILLING SCREW |
| 00846468014230 | SELF-DRILLING SCREW |
| 00846468014223 | SELF-DRILLING SCREW |
| 00846468014216 | SELF-DRILLING SCREW |
| 00846468014209 | SELF-DRILLING SCREW |
| 00846468014193 | SELF-DRILLING SCREW |
| 00846468014186 | SELF-DRILLING SCREW |
| 00846468014179 | SELF-DRILLING SCREW |
| 00846468014162 | SELF-DRILLING SCREW |
| 00846468014155 | SELF-DRILLING SCREW |
| 00846468014148 | SELF-DRILLING SCREW |
| 00846468014131 | SELF-DRILLING SCREW |
| 00846468014124 | SELF-DRILLING SCREW |
| 00846468014117 | SELF-DRILLING SCREW |
| 00846468014100 | SELF-DRILLING SCREW |
| 00846468014094 | SELF-DRILLING SCREW |
| 00846468014087 | SELF-DRILLING SCREW |
| 00846468014070 | SELF-DRILLING SCREW |
| 00846468014063 | SELF-DRILLING SCREW |
| 00846468014056 | SELF-DRILLING SCREW |
| 00846468014049 | SELF-DRILLING SCREW |
| 00846468014032 | SELF-DRILLING SCREW |
| 00846468014025 | SELF-DRILLING SCREW |
| 00846468014018 | SELF-DRILLING SCREW |
| 00846468014001 | SELF-DRILLING SCREW |
| 00846468013998 | SELF-DRILLING SCREW |
| 00846468013981 | SELF-DRILLING SCREW |
| 00846468013974 | SELF-DRILLING SCREW |
| 00846468013967 | SELF-DRILLING SCREW |
| 00846468013950 | SELF-DRILLING SCREW |
| 00846468013943 | SELF-DRILLING SCREW |
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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