Boundary

GUDID 90814008025506

Buttress Plate Screw 20mm 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.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Intervertebral-body internal spinal fixation system
Primary Device ID90814008025506
NIH Device Record Key44e40fb3-e230-4364-849d-ffb480da9123
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoundary
Version Model NumberALB-60L-20
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
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

Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com

Device Dimensions

Circumference6 Millimeter
Circumference6 Millimeter
Circumference6 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter
Length20 Millimeter
Circumference6 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time

Device Identifiers

Device Issuing AgencyDevice ID
GS190814008025506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


[90814008025506]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-20
Device Publish Date2018-02-28

On-Brand Devices [Boundary]

00814008029808Instrument, Lumbar Buttress Plate Ratchet Sport Grip AO Handle. The Boundary Anterior Lumbar Bu
00814008025589Instrument, Lumbar Buttress Plate Screw Inserter. The Boundary Anterior Lumbar Buttress Plate i
00814008025572Instrument, Lumbar Buttress Plate Inserter. The Boundary Anterior Lumbar Buttress Plate is inte
00814008025565Instrument, Lumbar Buttress Plate Tap. The Boundary Anterior Lumbar Buttress Plate is intended
00814008025558Instrument, Lumbar Buttress Plate Drill. The Boundary Anterior Lumbar Buttress Plate is intende
00814008025541Instrument, Lumbar Buttress Plate Awl. The Boundary Anterior Lumbar Buttress Plate is intended
90814008025537Buttress Plate Screw 35mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025520Buttress Plate Screw 30mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025513Buttress Plate Screw 25mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025506Buttress Plate Screw 20mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025490Buttress Plate Screw 35mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
90814008025483Buttress Plate Screw 30mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
90814008025476Buttress Plate Screw 25mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
90814008025469Buttress Plate Screw 20mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
90814008025452Buttress Plate Screw 35mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025445Buttress Plate Screw 30mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025438Buttress Plate Screw 25mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025421Buttress Plate Screw 20mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
90814008025414Buttress Plate Screw 35mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
90814008025407Buttress Plate Screw 30mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
90814008025391Buttress Plate Screw 25mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
90814008025384Buttress Plate Screw 20mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
90814008025377Buttress Plate 25mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
90814008025360Buttress Plate 25mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
90814008025353Buttress Plate 20mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
90814008025346Buttress Plate 20mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
90814008025339Buttress Plate 15mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
90814008025322Buttress Plate 15mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
00810005663908Lumbar Buttress Plate INSERT 1 Lid. The Boundary Anterior Lumbar Buttress Plate is intended to
00810005663892Lumbar Buttress Plate INSERT 1. The Boundary Anterior Lumbar Buttress Plate is intended to stab
00810005663885Lumbar Buttress Plate Case Lid. The Boundary Anterior Lumbar Buttress Plate is intended to stab
00810005663878Lumbar Buttress Plate Case Base. The Boundary Anterior Lumbar Buttress Plate is intended to sta
00810005665247Buttress Plate Screw 35mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior
00810005665230Buttress Plate Screw 25mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior
00810005665223Buttress Plate Screw 30mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior
00810005665216Buttress Plate Screw 20mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior
00810005665209Buttress Plate Screw 35mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante
00810005665193Buttress Plate Screw 30mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante
00810005665186Buttress Plate Screw 25mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante
00810005665179Buttress Plate Screw 20mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante

Trademark Results [Boundary]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOUNDARY
BOUNDARY
98027757 not registered Live/Pending
Ross Larson
2023-06-05
BOUNDARY
BOUNDARY
97919006 not registered Live/Pending
Boundary Digital, LLC
2023-05-03
BOUNDARY
BOUNDARY
90209468 not registered Live/Pending
Surgical Scalpels Technology (Shenzhen)Co., Ltd.
2020-09-25
BOUNDARY
BOUNDARY
88878895 not registered Live/Pending
Springfield, Inc.
2020-04-20
BOUNDARY
BOUNDARY
88424905 not registered Live/Pending
Boundary LLC
2019-05-10
BOUNDARY
BOUNDARY
88402964 not registered Live/Pending
JS Products, Inc.
2019-04-25
BOUNDARY
BOUNDARY
88402656 5896768 Live/Registered
Boundary Companies LLC
2019-04-25
BOUNDARY
BOUNDARY
87774117 5629412 Live/Registered
NVision BioMedical Technologies, LLC
2018-01-29
BOUNDARY
BOUNDARY
87655521 not registered Dead/Abandoned
JDTMK LLC
2017-10-23
BOUNDARY
BOUNDARY
87076859 not registered Dead/Abandoned
Ironstrike, LLC
2016-06-20
BOUNDARY
BOUNDARY
87055796 not registered Dead/Abandoned
Ironstrike, LLC
2016-06-01
BOUNDARY
BOUNDARY
86908242 5048979 Live/Registered
CI, LLC
2016-02-15

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