Leucadia Pedicle Screw System

GUDID 00844856075351

POLYAXIAL REDUCTION SCREW, 8 x 35mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00844856075351
NIH Device Record Keya9833275-026a-4dd1-874b-d044a7c8bda9
Commercial Distribution Discontinuation2017-11-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLeucadia Pedicle Screw System
Version Model NumberLC-PR0835
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter
Length35 Millimeter
Outer Diameter8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100844856075351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

[00844856075351]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

On-Brand Devices [Leucadia Pedicle Screw System]

00844856076037POLYAXIAL SCREW, 8mm x 90mm
00844856076020POLYAXIAL SCREW, 8mm x 80mm
00844856076013POLYAXIAL SCREW, 8mm x 70mm
00844856076006POLYAXIAL SCREW, 8mm x 65mm
00844856075993POLYAXIAL SCREW, 8mm x 60mm
00844856075986POLYAXIAL SCREW, 8mm x 55mm
00844856075979POLYAXIAL SCREW, 8mm x 50mm
00844856075962POLYAXIAL SCREW, 8mm x 45mm
00844856075955POLYAXIAL SCREW, 8mm x 40mm
00844856075948POLYAXIAL SCREW, 8mm x 35mm
00844856075931POLYAXIAL SCREW, 8mm x 30mm
00844856075924POLYAXIAL SCREW, 8mm x 100mm
00844856075917POLYAXIAL SCREW, 7mm x 90mm
00844856075900POLYAXIAL SCREW, 7mm x 80mm
00844856075894POLYAXIAL SCREW, 7mm x 70mm
00844856075887POLYAXIAL SCREW, 7mm x 65mm
00844856075870POLYAXIAL SCREW, 7mm x 60mm
00844856075863POLYAXIAL SCREW, 7mm x 55mm
00844856075856POLYAXIAL SCREW, 7mm x 50mm
00844856075849POLYAXIAL SCREW, 7mm x 45mm
00844856075832POLYAXIAL SCREW, 7mm x 40mm
00844856075825POLYAXIAL SCREW, 7mm x 35mm
00844856075818POLYAXIAL SCREW, 7mm x 30mm
00844856075801POLYAXIAL SCREW, 7mm x 100mm
00844856075795POLYAXIAL SCREW, 6mm x 65mm
00844856075788POLYAXIAL SCREW, 6mm x 60mm
00844856075771POLYAXIAL SCREW, 6mm x 55mm
00844856075764POLYAXIAL SCREW, 6mm x 50mm
00844856075757POLYAXIAL SCREW, 6mm x 45mm
00844856075740POLYAXIAL SCREW, 6mm x 40mm
00844856075733POLYAXIAL SCREW, 6mm x 35mm
00844856075726POLYAXIAL SCREW, 6mm x 30mm
00844856075719POLYAXIAL SCREW, 5mm x 65mm
00844856075702POLYAXIAL SCREW, 5mm x 60mm
00844856075696POLYAXIAL SCREW, 5mm x 55mm
00844856075689POLYAXIAL SCREW, 5mm x 50mm
00844856075672POLYAXIAL SCREW, 5mm x 45mm
00844856075665POLYAXIAL SCREW, 5mm x 40mm
00844856075658POLYAXIAL SCREW, 5mm x 35mm
00844856075641POLYAXIAL SCREW, 5mm x 30mm
008448560756344.5 X 55MM, POLYAXIAL SCREW
008448560756274.5 X 50MM, POLYAXIAL SCREW
008448560756104.5 X 45MM, POLYAXIAL SCREW
008448560756034.5 X 40MM, POLYAXIAL SCREW
008448560755974.5 X 35MM, POLYAXIAL SCREW
008448560755804.5 X 30MM, POLYAXIAL SCREW
008448560755734.5 X 25MM, POLYAXIAL SCREW
00844856075443POLYAXIAL REDUCTION SCREW, 8 x 90mm
00844856075436POLYAXIAL REDUCTION SCREW, 8 x 80mm
00844856075429POLYAXIAL REDUCTION SCREW, 8 x 70mm
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