primaLOK-SP

GUDID 00813210022393

Implant Sizer - 6mm

WENZEL SPINE, INC.

Spinal implant trial
Primary Device ID00813210022393
NIH Device Record Key97513b5b-2bff-4f33-a904-21451473fffa
Commercial Distribution StatusIn Commercial Distribution
Brand NameprimaLOK-SP
Version Model Number800-0306
Company DUNS832543255
Company NameWENZEL SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813210022393 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

[00813210022393]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-31
Device Publish Date2019-12-23

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00813210020016 - VariLift-L2020-02-24 The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and
00813210020023 - VariLift-L2020-02-24 The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and
00813210020030 - VariLift-C2020-02-24 The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interi
00813210020047 - VariLift-C2020-02-24 The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interi
00813210020054 - VariLift-C2020-02-24 The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interi
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