Preference 2 20-5500-045

GUDID M555205500045

6.0 Slot, HF Polyaxial Screw Assembly, ø5.5x45mm

AMEDICA CORPORATION

Bone-screw internal spinal fixation system, sterile
Primary Device IDM555205500045
NIH Device Record Keyd1027193-c836-4bc8-81c6-4939f5dfe92f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreference 2
Version Model NumberG
Catalog Number20-5500-045
Company DUNS028629553
Company NameAMEDICA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com

Device Dimensions

Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter
Outer Diameter5.5 Millimeter
Length45 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM555205500045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


[M555205500045]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-11-14
Device Publish Date2017-12-29

On-Brand Devices [Preference 2]

M555289000320Complex Spine System Hook, Transverse Process, Right 5.5
M555289000310Complex Spine System Hook, Transverse Process, Left 5.5
M555289000300Complex Spine System Hook, Transverse Process 5.5
M555289000210Complex Spine System Hook, Pedicle, Small 5.5
M555289000200Complex Spine System Hook, Pedicle, Large 5.5
M555289000160Complex Spine System Hook, Laminar Small, Narrow Blade 5.5
M555289000150Complex Spine System Hook, Laminar Small, Wide Blade 5.5
M555289000140Complex Spine System Hook, Laminar Large, Wide Blade 5.5
M555289000120Complex Spine System Hook, Laminar, Offset Left 5.5
M555289000110Complex Spine System Hook, Laminar, Angled Down 5.5
M555289000100Complex Spine System Hook, Laminar, Angled Up 5.5
M5552875091105.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 110mm
M5552875091005.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 100mm
M5552875090905.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 90mm
M5552875090805.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 80mm
M5552875090705.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 70mm
M5552875090605.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 60mm
M5552875090555.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 55mm
M5552875090505.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 50mm
M5552875090455.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 45mm
M5552875090405.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 40mm
M5552875090355.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 35mm
M5552875090305.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 30mm
M555287501110ø7.5 x 110mm Reduction Polyaxial Screw Assembly
M555287501100ø7.5 x 100mm Reduction Polyaxial Screw Assembly
M555287501090ø7.5 x 90mm Reduction Polyaxial Screw Assembly
M555287501080ø7.5 x 80mm Reduction Polyaxial Screw Assembly
M555287501070ø7.5 x 70mm Reduction Polyaxial Screw Assembly
M555287501060ø7.5 x 60mm Reduction Polyaxial Screw Assembly
M555287501055ø7.5 x 55mm Reduction Polyaxial Screw Assembly
M555287501050ø7.5 x 50mm Reduction Polyaxial Screw Assembly
M555287501045ø7.5 x 45mm Reduction Polyaxial Screw Assembly
M555287501040ø7.5 x 40mm Reduction Polyaxial Screw Assembly
M555287501035ø7.5 x 35mm Reduction Polyaxial Screw Assembly
M555287501030ø7.5 x 30mm Reduction Polyaxial Screw Assembly
M555287501025ø7.5 x 25mm Reduction Polyaxial Screw Assembly
M555287500110ø7.5 x 110mm Polyaxial Screw Assembly
M555287500100ø7.5 x 100mm Polyaxial Screw Assembly
M555287500090ø7.5 x 90mm Polyaxial Screw Assembly
M555287500080ø7.5 x 80mm Polyaxial Screw Assembly
M555287500070ø7.5 x 70mm Polyaxial Screw Assembly
M555287500060ø7.5 x 60mm Polyaxial Screw Assembly
M555287500055ø7.5 x 55mm Polyaxial Screw Assembly
M555287500050ø7.5 x 50mm Polyaxial Screw Assembly
M555287500045ø7.5 x 45mm Polyaxial Screw Assembly
M555287500040ø7.5 x 40mm Polyaxial Screw Assembly
M555287500035ø7.5 x 35mm Polyaxial Screw Assembly
M555287500030ø7.5 x 30mm Polyaxial Screw Assembly
M555287500025ø7.5 x 25mm Polyaxial Screw Assembly
M555287252110ø7.2 Triple Lead Closed Polyaxial Screw Assembly, 110mm

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