STREAMLINE™* TL SPINAL FIXATION SYSTEM 01-FXL-31
GUDID 00846468005443
FIXED CROSSLINK, OUTBOARD LOCKING
Pioneer Surgical Technology, Inc.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00846468005443 |
| NIH Device Record Key | c8741b1a-f3e3-4a11-8c19-8f0348be1f5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STREAMLINE™* TL SPINAL FIXATION SYSTEM |
| Version Model Number | 01-FXL-31 |
| Catalog Number | 01-FXL-31 |
| 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(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
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| Phone | +1(906)226-9909 |
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| 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(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083020488 [Primary] |
| GS1 | 00846468005443 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
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[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
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[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
Moist Heat or Steam Sterilization
[00846468005443]
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[00846468005443]
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[00846468005443]
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[00846468005443]
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-11-26 |
On-Brand Devices [STREAMLINE™* TL SPINAL FIXATION SYSTEM]
| 00846468062989 | PEDICLE SCREW, POLYAXIAL |
| 00846468062972 | PEDICLE SCREW, POLYAXIAL |
| 00846468062965 | PEDICLE SCREW, POLYAXIAL |
| 00846468062958 | PEDICLE SCREW, POLYAXIAL |
| 00846468062941 | PEDICLE SCREW, POLYAXIAL |
| 00846468062880 | PEDICLE SCREW, POLYAXIAL |
| 00846468062873 | PEDICLE SCREW, POLYAXIAL |
| 00846468062866 | PEDICLE SCREW, POLYAXIAL |
| 00846468062859 | PEDICLE SCREW, POLYAXIAL |
| 00846468062842 | PEDICLE SCREW, POLYAXIAL |
| 00846468062835 | PEDICLE SCREW, POLYAXIAL |
| 00846468062781 | PEDICLE SCREW, POLYAXIAL |
| 00846468062774 | PEDICLE SCREW, POLYAXIAL |
| 00846468062767 | PEDICLE SCREW, POLYAXIAL |
| 00846468062750 | PEDICLE SCREW, POLYAXIAL |
| 00846468057206 | OPEN PARALLEL ROD CONNECTOR |
| 00846468057190 | CLOSED PARALLEL ROD CONNECTOR |
| 00846468056865 | REDUCTION SCREW |
| 00846468056858 | REDUCTION SCREW |
| 00846468056841 | REDUCTION SCREW |
| 00846468056834 | REDUCTION SCREW |
| 00846468056827 | REDUCTION SCREW |
| 00846468056810 | REDUCTION SCREW |
| 00846468056803 | REDUCTION SCREW |
| 00846468056711 | REDUCTION SCREW |
| 00846468056704 | REDUCTION SCREW |
| 00846468056698 | REDUCTION SCREW |
| 00846468056681 | REDUCTION SCREW |
| 00846468056674 | REDUCTION SCREW |
| 00846468056667 | REDUCTION SCREW |
| 00846468056650 | REDUCTION SCREW |
| 00846468056643 | REDUCTION SCREW |
| 00846468056636 | REDUCTION SCREW |
| 00846468056629 | REDUCTION SCREW |
| 00846468056612 | REDUCTION SCREW |
| 00846468056605 | REDUCTION SCREW |
| 00846468056599 | REDUCTION SCREW |
| 00846468056582 | REDUCTION SCREW |
| 00846468053710 | LATERAL OFFSET CONNECTOR |
| 00846468053703 | LATERAL OFFSET CONNECTOR |
| 00846468053697 | LATERAL OFFSET CONNECTOR |
| 00846468053369 | PEDICLE SCREW, FIXED |
| 00846468053352 | PEDICLE SCREW, FIXED |
| 00846468053345 | PEDICLE SCREW, FIXED |
| 00846468053338 | PEDICLE SCREW, FIXED |
| 00846468053321 | PEDICLE SCREW, FIXED |
| 00846468053314 | PEDICLE SCREW, FIXED |
| 00846468053307 | PEDICLE SCREW, FIXED |
| 00846468053215 | PEDICLE SCREW, FIXED |
| 00846468053208 | PEDICLE SCREW, FIXED |
Trademark Results [STREAMLINE]
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