Duns Number:047486041
Device Description: Buttress Plate Screw 35mm long, 6.0mm circumference, locking. The Boundary Anterior Lumba Buttress Plate Screw 35mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Catalog Number
-
Brand Name
Boundary
Version/Model Number
ALB-60L-35
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K173091
Product Code
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
e817e7d4-156f-4899-93a9-ca139483a14d
Public Version Date
January 20, 2020
Public Version Number
5
DI Record Publish Date
February 28, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 461 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1046 |