Streamline TL Spinal Fixation System 01-PA-775-55

GUDID 00191083009155

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
Primary Device ID00191083009155
NIH Device Record Keye283af69-3400-46ef-a06b-d1f8d53e3cc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameStreamline TL Spinal Fixation System
Version Model Number01-PA-775-55
Catalog Number01-PA-775-55
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100191083009155 [Primary]
GS100846468016623 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


[00191083009155]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-05
Device Publish Date2021-06-25

On-Brand Devices [Streamline TL Spinal Fixation System]

00846468080839Instrument Case, Empty
00846468080822Instrument Case, Empty
00846468080815Instrument Case, Empty
00846468080808Instrument Case, Empty
00846468080792Caddy, Crosslink, Variable, Empty
00846468080785Case, Crosslink, Empty
00846468080778Long Rod Caddy, Empty
00846468080761Long Rod Caddy, Empty
00846468080754Caddy, Crosslink, Fixed, Empty
00846468080747Lateral Offset Caddy, Empty
00846468080730Caddy, Rod Connector, Empty
00846468080723Implant Case, Empty
00846468080716Medium Rod Caddy, Empty
00846468080709Small Rod Caddy, Empty
00846468080693Large Rod Caddy, Empty
008464680806869.5mm Screw Caddy, Long, Polyaxial, Empty
008464680806799.5mm Screw Caddy, Polyaxial, Empty
008464680806628.5mm Screw Caddy, Long, Polyaxial, Empty
008464680806558.5mm Screw Caddy, Polyaxial, Empty
008464680806487.5mm Screw Caddy, Long, Polyaxial, Empty
008464680806316.5mm Screw Caddy, Long, Polyaxial, Empty
008464680806244.5mm Screw Caddy, Polyaxial, Empty
00846468080617Screw Caddy, Cannulated, Polyaxial, Reduction
00846468080600Screw Caddy, Cannulated, Polyaxial, Reduction
00846468080594Screw Caddy, Cannulated, Polyaxial, Reduction
008464680805877.5mm Screw Caddy, Fixed, Empty
008464680805706.5mm Screw Caddy, Fixed, Empty
008464680805635.5mm Screw Caddy, Fixed, Empty
008464680805564.5mm Screw Caddy, Fixed, Empty
008464680805497.5mm Screw Caddy, Polyaxial, Empty
008464680805326.5mm Screw Caddy, Polyaxial, Empty
008464680805255.5mm Screw Caddy, Polyaxial, Empty
00846468080518Implant Case, Empty
00846468079734CROSSLINK HOLDER
00846468006907Set Screw Caddy, Empty
00846468006631CROSSLINK COUNTER TORQUE TUBE
00846468006624VARIABLE CROSSLINK BENDER MALE
00846468006617VARIABLE CROSSLINK BENDER FEMALE
00846468006600FIXED CROSSLINK BENDER RIGHT
00846468006594FIXED CROSSLINK BENDER LEFT
00846468006549CADDY, X-LINK, FIXED
00846468006402CROSSLINK TORQUE HANDLE
00846468006396CROSSLINK PROVISIONAL INSERTER
00846468006389CROSSLINK GAUGE
00846468006372CROSSLINK FINAL DRIVER
00846468001834STREAMLINE TL, BANDED PEDICLE MARKER
00846468000530STREAMLINE TL, REDUCTION SCREW DEROTATOR
00846468000103STREAMLINE TL, DISTRACTOR, STRAIGHT TIP
00846468000097STREAMLINE TL, COMPRESSOR, STRAIGHT TIP
00846468032951STREAMLINE TL, ROD WRENCH,ORIENTATED HEX

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.