Dark Star Deformity DSDTC-8530

GUDID B07510111485300

Cannulated Tower, Double Lead Pedicle Screw - Ø8.5mm x 30mm

Republic Spine, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB07510111485300
NIH Device Record Key26def0f2-385b-470b-8844-d115f30baa81
Commercial Distribution StatusIn Commercial Distribution
Brand NameDark Star Deformity
Version Model Number101114-C-8530
Catalog NumberDSDTC-8530
Company DUNS061891717
Company NameRepublic Spine, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com
Phone561-334-2421
Emailjames@rspine.com

Device Dimensions

Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter
Outer Diameter8.5 Millimeter
Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07510111485300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

[B07510111485300]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-03
Device Publish Date2024-06-25

On-Brand Devices [Dark Star Deformity]

B0751002205560S0Polyaxial Screw, Tower - Ø5.5mm x 60mm
B0751002205560C0Polyaxial Screw, Cannulated Tower - Ø5.5mm x 60mm
B0751002205555S0Polyaxial Screw, Tower - Ø5.5mm x 55mm
B0751002205555C0Polyaxial Screw, Cannulated Tower - Ø5.5mm x 55mm
B07510020885900Cannulated Polyaxial Screw - Ø8.5mm x 90mm
B07510020885800Cannulated Polyaxial Screw - Ø8.5mm x 80mm
B07510020885700Cannulated Polyaxial Screw - Ø8.5mm x 70mm
B075100208851100Cannulated Polyaxial Screw - Ø8.5mm x 110mm
B075100208851000Cannulated Polyaxial Screw - Ø8.5mm x 100mm
B07510020875900Cannulated Polyaxial Screw - Ø7.5mm x 90mm
B07510020875800Cannulated Polyaxial Screw - Ø7.5mm x 80mm
B07510020875700Cannulated Polyaxial Screw - Ø7.5mm x 70mm
B07510020875600Cannulated Polyaxial Screw - Ø7.5mm x 60mm
B075100208751100Cannulated Polyaxial Screw - Ø7.5mm x 110mm
B075100208751000Cannulated Polyaxial Screw - Ø7.5mm x 100mm
B07510020855600Cannulated Polyaxial Screw - Ø5.5mm x 60mm
B0751002206590S0Polyaxial Screw, Tower - Ø6.5mm x 90mm
B0751002206590C0Polyaxial Screw, Cannulated Tower - Ø6.5mm x 90mm
B0751002206580S0Polyaxial Screw, Tower - Ø6.5mm x 80mm
B0751002206580C0Polyaxial Screw, Cannulated Tower - Ø6.5mm x 80mm
B0751002206570S0Polyaxial Screw, Tower - Ø6.5mm x 70mm
B0751002206570C0Polyaxial Screw, Cannulated Tower - Ø6.5mm x 70mm
B0751002206560S0Polyaxial Screw, Tower - Ø6.5mm x 60mm
B07510022065100S0Polyaxial Screw, Tower - Ø6.5mm x 100mm
B07510022065100C0Polyaxial Screw, Cannulated Tower - Ø6.5mm x 100mm
B07510020855550Cannulated Polyaxial Screw - Ø5.5mm x 55mm
B07510023585900Cannulated Polyaxial Reduction Screw - Ø8.5mm x 90mm
B07510023585800Cannulated Polyaxial Reduction Screw - Ø8.5mm x 80mm
B07510023585700Cannulated Polyaxial Reduction Screw - Ø8.5mm x 70mm
B07510023585600Cannulated Polyaxial Reduction Screw - Ø8.5mm x 60mm
B075100235851100Cannulated Polyaxial Reduction Screw - Ø8.5mm x 110mm
B07510023585100Cannulated Polyaxial Reduction Screw - Ø8.5mm x 100mm
B07510023575900Cannulated Polyaxial Reduction Screw - Ø7.5mm x 90mm
B07510023575800Cannulated Polyaxial Reduction Screw - Ø7.5mm x 80mm
B07510023575700Cannulated Polyaxial Reduction Screw - Ø7.5mm x 70mm
B07510023575600Cannulated Polyaxial Reduction Screw - Ø7.5mm x 60mm
B075100235751100Cannulated Polyaxial Reduction Screw - Ø7.5mm x 110mm
B075100235751000Cannulated Polyaxial Reduction Screw - Ø7.5mm x 100mm
B07510023565500Cannulated Polyaxial Reduction Screw - Ø6.5mm x 50mm
B07510023555600Cannulated Polyaxial Reduction Screw - Ø5.5mm x 60mm
B0751002208590S0Polyaxial Screw, Tower - Ø8.5mm x 90mm
B0751002208590C0Polyaxial Screw, Cannulated Tower - Ø8.5mm x 90mm
B0751002208580S0Polyaxial Screw, Tower - Ø8.5mm x 80mm
B0751002208580C0Polyaxial Screw, Cannulated Tower - Ø8.5mm x 80mm
B0751002208570S0Polyaxial Screw, Tower - Ø8.5mm x 70mm
B0751002208570C0Polyaxial Screw, Cannulated Tower - Ø8.5mm x 70mm
B07510022085110S0Polyaxial Screw, Tower - Ø8.5mm x 110mm
B07510022085110C0Polyaxial Screw, Cannulated Tower - Ø8.5mm x 110mm
B07510022085100S0Polyaxial Screw, Tower - Ø8.5mm x 100mm
B07510022085100C0Polyaxial Screw, Cannulated Tower - Ø8.5mm x 100mm
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