primaLOK FF - primaLOK FF 35mm Implant Assembly, Sterile - WENZEL SPINE, INC.

Duns Number:832543255

Device Description: primaLOK FF 35mm Implant Assembly, Sterile 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.

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More Product Details

Catalog Number

-

Brand Name

primaLOK FF

Version/Model Number

800-1135-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102438

Product Code Details

Product Code

MRW

Product Code Name

System, Facet Screw Spinal Device

Device Record Status

Public Device Record Key

8abadc37-8f26-4327-8199-67b9c245a56f

Public Version Date

July 27, 2018

Public Version Number

1

DI Record Publish Date

June 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WENZEL SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 71
U Unclassified 9