primaLOK FF

GUDID 00813210021976

primaLOK FF 35mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

WENZEL SPINE, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00813210021976
NIH Device Record Key8abadc37-8f26-4327-8199-67b9c245a56f
Commercial Distribution StatusIn Commercial Distribution
Brand NameprimaLOK FF
Version Model Number800-1135-00
Company DUNS832543255
Company NameWENZEL SPINE, INC.
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

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

Device Dimensions

Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813210021976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSystem, Facet Screw Spinal Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-27
Device Publish Date2018-06-26

On-Brand Devices [primaLOK FF]

00813210022034Threaded Implant Holder Shaft - Solid
00813210022027Threaded Implant Holder Shaft - Cannulated
00813210022010Implant Driver
00813210022003Removal Driver
00813210021990primaLOK FF 45mm Implant Assembly, Sterile
00813210021983primaLOK FF 40mm Implant Assembly, Sterile
00813210021976primaLOK FF 35mm Implant Assembly, Sterile
00813210021969primaLOK FF 30mm Implant Assembly, Sterile
00813210021952primaLOK FF 25mm Implant Assembly, Sterile
008132100221573mm Cannulated Power Drill
00813210022133Ratcheting Driver Handle
00813210022126Cannula Inserter
00813210022119Single Bevel Access Needle (sterile, single use)
00813210022102Access Needle (sterile, single use)
00813210022096EMG Cannula
00813210022089Standard Cannula
00813210022072Guide Wire Stiffener
00813210022065Cannulated Tap
00813210022041Guide Wire (single use, disposable)
00813210021945Percutaneous Instrument Case
00813210021938Instrument Case
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