LANCER Pedicle Screw System

GUDID 00840996188517

LANCER,SCREW,POLYAXIAL,NF,6.5X55

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996188517
NIH Device Record Keyf3b1b8be-2e3e-49ff-b360-ff721f3ee86d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLANCER Pedicle Screw System
Version Model NumberMT31-6555
Company DUNS078293017
Company NameChoice Spine, LP
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996188517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

[00840996188517]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

On-Brand Devices [LANCER Pedicle Screw System]

00840996174336LANCER,SCREW,POLYAXIAL,6.0X110
00840996174329LANCER,SCREW,POLYAXIAL,6.0X100
00840996174312LANCER,SCREW,POLYAXIAL,6.0X90
00840996174305LANCER,SCREW,POLYAXIAL,6.0X80
00840996174299LANCER,SCREW,POLYAXIAL,6.0X75
00840996174282LANCER,SCREW,POLYAXIAL,6.0X70
00840996174275LANCER,SCREW,POLYAXIAL,6.0X65
00840996174268LANCER,SCREW,POLYAXIAL,6.0X60
00840996174251LANCER,SCREW,POLYAXIAL,6.0X55
00840996174244LANCER,SCREW,POLYAXIAL,6.0X50
00840996174237LANCER,SCREW,POLYAXIAL,6.0X45
00840996174220LANCER,SCREW,POLYAXIAL,6.0X40
00840996174213LANCER,SCREW,POLYAXIAL,6.0X35
00840996174206LANCER,SCREW,POLYAXIAL,6.0X30
00840996174190LANCER,SCREW,POLYAXIAL,6.0X25
00840996174183LANCER,SCREW,POLYAXIAL,7.0X110
00840996174176LANCER,SCREW,POLYAXIAL,7.0X100
00840996174169LANCER,SCREW,POLYAXIAL,7.0X90
00840996174152LANCER,SCREW,POLYAXIAL,7.0X80
00840996174145LANCER,SCREW,POLYAXIAL,7.0X75
00840996174138LANCER,SCREW,POLYAXIAL,7.0X70
00840996174121LANCER,SCREW,POLYAXIAL,7.0X65
00840996174114LANCER,SCREW,POLYAXIAL,7.0X60
00840996174107LANCER,SCREW,POLYAXIAL,7.0X55
00840996174091LANCER,SCREW,POLYAXIAL,7.0X50
00840996174084LANCER,SCREW,POLYAXIAL,7.0X45
00840996174077LANCER,SCREW,POLYAXIAL,7.0X40
00840996174060LANCER,SCREW,POLYAXIAL,7.0X35
00840996174053LANCER,SCREW,POLYAXIAL,7.0X30
00840996174046LANCER,SCREW,POLYAXIAL,7.0X25
00840996164849LANCER,ROD,DUAL-RADIUS,TI,5.5X110
00840996164832LANCER,ROD,DUAL-RADIUS,TI,5.5X100
00840996164825LANCER,ROD,DUAL-RADIUS,TI,5.5X90
00840996164818LANCER,ROD,DUAL-RADIUS,TI,5.5X80
00840996164801LANCER,ROD,DUAL-RADIUS,TI,5.5X70
00840996164795LANCER,ROD,DUAL-RADIUS,TI,5.5X60
00840996164788LANCER,ROD,DUAL-RADIUS,TI,5.5X50
00840996164771LANCER,ROD,DUAL-RADIUS,TI,5.5X40
00840996161541LANCER,LATERAL CONN, 40MM OFFSET, STR
00840996161534LANCER,LATERAL CONN, 35MM OFFSET
00840996161527LANCER,LATERAL CONN, 30MM OFFSET, STR
00840996161510LANCER,LATERAL CONN, 25MM OFFSET, STR
00840996161503LANCER,LATERAL CONN, 20MM OFFSET, STR
00840996161497LANCER,LATERAL CONN, 15MM OFFSET, STR
008409961614355.5 DEFORMITY,CONNECTOR DRIVER
00840996149884LANCER,SCREW,POLY,REDUCTION,12.5X110
00840996149877LANCER,SCREW,POLY,REDUCTION,12.5X100
00840996149860LANCER,SCREW,POLY,REDUCTION,12.5X90
00840996149853LANCER,SCREW,POLY,REDUCTION,12.5X80
00840996149846LANCER,SCREW,POLY,REDUCTION,12.5X75
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