STREAMLINE®* TL SPINAL FIXATION SYSTEM 01-PA-875-40
GUDID 00846468016746
PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00846468016746 |
| NIH Device Record Key | 227be864-62f6-462c-9145-be36530249c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STREAMLINE®* TL SPINAL FIXATION SYSTEM |
| Version Model Number | 01-PA-875-40 |
| Catalog Number | 01-PA-875-40 |
| 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 |
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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 |
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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 |
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| 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 |
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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 |
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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 |
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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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083009216 [Primary] |
| GS1 | 00846468016746 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
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[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
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[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
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[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
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[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
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[00846468016746]
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[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
Moist Heat or Steam Sterilization
[00846468016746]
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 | 2015-11-26 |
On-Brand Devices [STREAMLINE®* TL SPINAL FIXATION SYSTEM]
| 00846468016944 | PEDICLE SCREW, POLYAXIAL |
| 00846468016937 | PEDICLE SCREW, POLYAXIAL |
| 00846468016920 | PEDICLE SCREW, POLYAXIAL |
| 00846468016913 | PEDICLE SCREW, POLYAXIAL |
| 00846468016906 | PEDICLE SCREW, POLYAXIAL |
| 00846468016890 | PEDICLE SCREW, POLYAXIAL |
| 00846468016883 | PEDICLE SCREW, POLYAXIAL |
| 00846468016876 | PEDICLE SCREW, POLYAXIAL |
| 00846468016869 | PEDICLE SCREW, POLYAXIAL |
| 00846468016845 | PEDICLE SCREW, POLYAXIAL |
| 00846468016821 | PEDICLE SCREW, POLYAXIAL |
| 00846468016807 | PEDICLE SCREW, POLYAXIAL |
| 00846468016784 | PEDICLE SCREW, POLYAXIAL |
| 00846468016777 | PEDICLE SCREW, POLYAXIAL |
| 00846468016760 | PEDICLE SCREW, POLYAXIAL |
| 00846468016753 | PEDICLE SCREW, POLYAXIAL |
| 00846468016746 | PEDICLE SCREW, POLYAXIAL |
| 00846468016739 | PEDICLE SCREW, POLYAXIAL |
| 00846468016722 | PEDICLE SCREW, POLYAXIAL |
| 00846468016715 | PEDICLE SCREW, POLYAXIAL |
| 00846468016678 | PEDICLE SCREW, POLYAXIAL |
| 00846468016630 | PEDICLE SCREW, POLYAXIAL |
| 00846468016623 | PEDICLE SCREW, POLYAXIAL |
| 00846468016616 | PEDICLE SCREW, POLYAXIAL |
| 00846468016609 | PEDICLE SCREW, POLYAXIAL |
| 00846468016593 | PEDICLE SCREW, POLYAXIAL |
| 00846468016586 | PEDICLE SCREW, POLYAXIAL |
| 00846468016579 | PEDICLE SCREW, POLYAXIAL |
| 00846468016562 | PEDICLE SCREW, POLYAXIAL |
| 00846468016418 | PEDICLE SCREW, POLYAXIAL |
| 00846468016401 | PEDICLE SCREW, POLYAXIAL |
| 00846468016395 | PEDICLE SCREW, POLYAXIAL |
| 00846468016388 | PEDICLE SCREW, POLYAXIAL |
| 00846468016371 | PEDICLE SCREW, POLYAXIAL |
| 00846468016364 | PEDICLE SCREW, POLYAXIAL |
| 00846468016357 | PEDICLE SCREW, POLYAXIAL |
| 00846468016258 | PEDICLE SCREW, POLYAXIAL |
| 00846468016241 | PEDICLE SCREW, POLYAXIAL |
| 00846468016234 | PEDICLE SCREW, POLYAXIAL |
| 00846468016227 | PEDICLE SCREW, POLYAXIAL |
| 00846468016210 | PEDICLE SCREW, POLYAXIAL |
| 00846468016203 | PEDICLE SCREW, POLYAXIAL |
| 00846468016128 | PEDICLE SCREW, POLYAXIAL |
| 00846468016111 | PEDICLE SCREW, POLYAXIAL |
| 00846468016104 | PEDICLE SCREW, POLYAXIAL |
| 00846468016098 | PEDICLE SCREW, POLYAXIAL |
| 00846468016081 | PEDICLE SCREW, POLYAXIAL |
| 00846468016074 | PEDICLE SCREW, POLYAXIAL |
Trademark Results [STREAMLINE]
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