Primary Device ID | B07510111465800 |
NIH Device Record Key | f0f7bf86-cd7d-4e90-94d5-36af66fdc5c7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dark Star Deformity |
Version Model Number | 101114-C-6580 |
Catalog Number | DSDTC-6580 |
Company DUNS | 061891717 |
Company Name | Republic Spine, LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 | false |
OTC Over-The-Counter | false |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com | |
Phone | 561-334-2421 |
james@rspine.com |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Outer Diameter | 6.5 Millimeter |
Length | 80 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B07510111465800 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
[B07510111465800]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-03 |
Device Publish Date | 2024-06-25 |
B0751002205560S0 | Polyaxial Screw, Tower - Ø5.5mm x 60mm |
B0751002205560C0 | Polyaxial Screw, Cannulated Tower - Ø5.5mm x 60mm |
B0751002205555S0 | Polyaxial Screw, Tower - Ø5.5mm x 55mm |
B0751002205555C0 | Polyaxial Screw, Cannulated Tower - Ø5.5mm x 55mm |
B07510020885900 | Cannulated Polyaxial Screw - Ø8.5mm x 90mm |
B07510020885800 | Cannulated Polyaxial Screw - Ø8.5mm x 80mm |
B07510020885700 | Cannulated Polyaxial Screw - Ø8.5mm x 70mm |
B075100208851100 | Cannulated Polyaxial Screw - Ø8.5mm x 110mm |
B075100208851000 | Cannulated Polyaxial Screw - Ø8.5mm x 100mm |
B07510020875900 | Cannulated Polyaxial Screw - Ø7.5mm x 90mm |
B07510020875800 | Cannulated Polyaxial Screw - Ø7.5mm x 80mm |
B07510020875700 | Cannulated Polyaxial Screw - Ø7.5mm x 70mm |
B07510020875600 | Cannulated Polyaxial Screw - Ø7.5mm x 60mm |
B075100208751100 | Cannulated Polyaxial Screw - Ø7.5mm x 110mm |
B075100208751000 | Cannulated Polyaxial Screw - Ø7.5mm x 100mm |
B07510020855600 | Cannulated Polyaxial Screw - Ø5.5mm x 60mm |
B0751002206590S0 | Polyaxial Screw, Tower - Ø6.5mm x 90mm |
B0751002206590C0 | Polyaxial Screw, Cannulated Tower - Ø6.5mm x 90mm |
B0751002206580S0 | Polyaxial Screw, Tower - Ø6.5mm x 80mm |
B0751002206580C0 | Polyaxial Screw, Cannulated Tower - Ø6.5mm x 80mm |
B0751002206570S0 | Polyaxial Screw, Tower - Ø6.5mm x 70mm |
B0751002206570C0 | Polyaxial Screw, Cannulated Tower - Ø6.5mm x 70mm |
B0751002206560S0 | Polyaxial Screw, Tower - Ø6.5mm x 60mm |
B07510022065100S0 | Polyaxial Screw, Tower - Ø6.5mm x 100mm |
B07510022065100C0 | Polyaxial Screw, Cannulated Tower - Ø6.5mm x 100mm |
B07510020855550 | Cannulated Polyaxial Screw - Ø5.5mm x 55mm |
B07510023585900 | Cannulated Polyaxial Reduction Screw - Ø8.5mm x 90mm |
B07510023585800 | Cannulated Polyaxial Reduction Screw - Ø8.5mm x 80mm |
B07510023585700 | Cannulated Polyaxial Reduction Screw - Ø8.5mm x 70mm |
B07510023585600 | Cannulated Polyaxial Reduction Screw - Ø8.5mm x 60mm |
B075100235851100 | Cannulated Polyaxial Reduction Screw - Ø8.5mm x 110mm |
B07510023585100 | Cannulated Polyaxial Reduction Screw - Ø8.5mm x 100mm |
B07510023575900 | Cannulated Polyaxial Reduction Screw - Ø7.5mm x 90mm |
B07510023575800 | Cannulated Polyaxial Reduction Screw - Ø7.5mm x 80mm |
B07510023575700 | Cannulated Polyaxial Reduction Screw - Ø7.5mm x 70mm |
B07510023575600 | Cannulated Polyaxial Reduction Screw - Ø7.5mm x 60mm |
B075100235751100 | Cannulated Polyaxial Reduction Screw - Ø7.5mm x 110mm |
B075100235751000 | Cannulated Polyaxial Reduction Screw - Ø7.5mm x 100mm |
B07510023565500 | Cannulated Polyaxial Reduction Screw - Ø6.5mm x 50mm |
B07510023555600 | Cannulated Polyaxial Reduction Screw - Ø5.5mm x 60mm |
B0751002208590S0 | Polyaxial Screw, Tower - Ø8.5mm x 90mm |
B0751002208590C0 | Polyaxial Screw, Cannulated Tower - Ø8.5mm x 90mm |
B0751002208580S0 | Polyaxial Screw, Tower - Ø8.5mm x 80mm |
B0751002208580C0 | Polyaxial Screw, Cannulated Tower - Ø8.5mm x 80mm |
B0751002208570S0 | Polyaxial Screw, Tower - Ø8.5mm x 70mm |
B0751002208570C0 | Polyaxial Screw, Cannulated Tower - Ø8.5mm x 70mm |
B07510022085110S0 | Polyaxial Screw, Tower - Ø8.5mm x 110mm |
B07510022085110C0 | Polyaxial Screw, Cannulated Tower - Ø8.5mm x 110mm |
B07510022085100S0 | Polyaxial Screw, Tower - Ø8.5mm x 100mm |
B07510022085100C0 | Polyaxial Screw, Cannulated Tower - Ø8.5mm x 100mm |